OrbusNeich Medical (Shenzhen) Co., Ltd.: PMA supplement approved for Scoreflex NC Scoring PTCA Catheter
OrbusNeich Medical (Shenzhen) Co., Ltd. (Shenzhen): PMA supplement approved for Scoreflex NC Scoring PTCA Catheter. Dated 97 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: 499 related FdaApprovalPulse records and the 4-column CSV export.
| Field | Value |
|---|---|
| Sponsor | OrbusNeich Medical (Shenzhen) Co., Ltd. |
| Product | Scoreflex NC Scoring PTCA Catheter |
| Generic / ingredient | Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring |
| Approval | PMA supplement (device change) |
| Application | P200041 S005 |
| Decided | 2026-07-31 |
| Panel / class | Cardiovascular |
| Sponsor location | Shenzhen |
| Peer records CSV (500 records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
Watch OrbusNeich Medical (Shenzhen) Co., Ltd.
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.
Free first: a 10-record sample of records
See the real columns before you buy. One confirmation email, nothing else unless you opt in.
Unlock OrbusNeich Medical (Shenzhen) Co. + 500 peer 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: 2026-07-31
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
Top FdaApprovalPulse records: Instylla, Inc. · Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) · Cerenovus, Inc. · Advanced Medical Solutions Limited · Lenstec, Inc. · 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.
30 / 100 Score
What is the FdaApprovalPulse record for OrbusNeich Medical (Shenzhen) Co., Ltd. in Shenzhen?
The FDA approved Scoreflex NC Scoring PTCA Catheter (P200041 S005) for OrbusNeich Medical (Shenzhen) Co., Ltd. on 2026-07-31: PMA supplement (device change).
How does OrbusNeich Medical (Shenzhen) Co., Ltd. compare to other FdaApprovalPulse records?
It is 97 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.
OrbusNeich Medical (Shenzhen) Co., Ltd. vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| OrbusNeich Medical (Shenzhen) Co., Ltd. | Shenzhen | 2026-07-31 |
| 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)
How to monitor OrbusNeich Medical (Shenzhen) Co., Ltd. and peer pma supplement (device change) records
Get new FdaApprovalPulse records like OrbusNeich Medical (Shenzhen) Co., Ltd. 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.