Siemens Healthcare Diagnostics, Inc.: PMA supplement approved for Atellica IM Total PSA II (tPSAII)
Siemens Healthcare Diagnostics, Inc. (Tarrytown, New York): PMA supplement approved for Atellica IM Total PSA II (tPSAII). Dated 71 days ago, it serves as a historical benchmark. Score 30/100. As of 2026-11-04, from openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration).
Data as of · Compiled by Zalwin from openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration)
Free preview: all 8 published fields of this record are shown below. Locked: 3 related NY FdaApprovalPulse records and the 4-column CSV export.
| Field | Value |
|---|---|
| Sponsor | Siemens Healthcare Diagnostics, Inc. |
| Product | Atellica IM Total PSA II (tPSAII) |
| Generic / ingredient | Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer |
| Approval | PMA supplement (device change) |
| Application | P240021 S001 |
| Decided | 2026-08-26 |
| Panel / class | Immunology |
| Sponsor location | Tarrytown, NY |
| Peer records CSV (4 NY records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
Watch Siemens Healthcare Diagnostics, Inc.
Free email alert. Alert me when this company gets a new filing, lien, permit, contract or expiry in this feed. One confirmation email; unsubscribe any time.
Free for 1 company. More companies from $9/mo (25), $49/mo (500 + CSV), $199/mo (500 + CSV + API). Cancel any time from the link in every email.
Unlock Siemens Healthcare Diagnostics + all 4 NY records (CSV)
Instant CSV download · Card, Apple Pay, Google Pay or Link via Stripe · No account required
CSV columns: Sponsor · Product · Approval · Decided · official source URL
- Source agency: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration)
- Record date: 2026-08-26
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
Top FdaApprovalPulse records (NY first): Bausch & Lomb, Inc. · NuMED, Inc. · Siemens Healthcare Diagnostics, Inc. · Instylla, Inc. · Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) · Browse all by state and category →
LIVE PUBLIC DATA Source: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration) · Last refreshed: Wed, 04 Nov 2026 06:06:18 GMT
Is this your business? Add a "Listed on Zalwin" badge to your site
Paste this snippet into your website. It links to this public record; nothing is tracked on your site.
Peer benchmark and outreach value: Siemens Healthcare Diagnostics, Inc. and 4 New York peers
- New York FdaApprovalPulse records like this one: 4
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every New York peer: $800 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
30 / 100 Score
What is the FdaApprovalPulse record for Siemens Healthcare Diagnostics, Inc. in Tarrytown, New York?
The FDA approved Atellica IM Total PSA II (tPSAII) (P240021 S001) for Siemens Healthcare Diagnostics, Inc. on 2026-08-26: PMA supplement (device change).
How does Siemens Healthcare Diagnostics, Inc. compare to other New York FdaApprovalPulse records?
It is 71 days old; check the official source for later updates before acting. Its Score of 30/100 is modest; treat it as background rather than a priority.
Siemens Healthcare Diagnostics, Inc. vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Siemens Healthcare Diagnostics, Inc. | Tarrytown, NY | 2026-08-26 |
| Instylla, Inc. | Bedford, MA | 2026-10-23 |
| Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) | Tucson, AZ | 2026-10-23 |
| Cerenovus, Inc. | Miami, FL | 2026-10-23 |
Related records
FdaApprovalPulse: PMA supplement (device change) FdaApprovalPulse: records in New York
More New York public-record feeds
New York City DOB Permit Issuance Pulse in New York New SBA 7(a) & 504 Loan Approvals in New York Industrial Environmental Noncompliance Radar in New York New Liquor & Cannabis Licenses and Pending Applications (NY, CO, OR, MO, TX) in New York New York Lead Testing in School Drinking Water Pulse in New York Credit Union Quarterly Changes, Mergers & New Charters (NCUA Call Reports) in New York New York Council On The Arts Grant Awards Pulse in New York New York College Access Challenge Grant Program Subgrantees Pulse in New York
How to monitor Siemens Healthcare Diagnostics, Inc. and peer pma supplement (device change) records
Get new FdaApprovalPulse records like Siemens Healthcare Diagnostics, Inc. by email (free, weekly)
We email one confirmation link now; the weekly digest starts only after you confirm. One-click unsubscribe in every email.
Double opt-in: nothing is sent until you click the confirmation link. One-click unsubscribe.
Get new approvals in your categories
FdaApprovalPulse emails new device and drug approvals matching your approval types.
✓ Read-only, live public data · Key and unlock right after payment · Card, Apple Pay, Google Pay or Link via Stripe · Refunds on request within 14 days
From openFDA (PMA and Drugs@FDA). openFDA can lag FDA decisions by days to weeks. Drug supplement types follow the FDA submission class (labeling and REMS, manufacturing/CMC, efficacy, other). Company and product level only. Verify on FDA databases before relying on an approval.