Impulse Dynamics (Usa), Inc.: PMA supplement approved for OPTIMIZER Smart System
Impulse Dynamics (Usa), Inc. (Marlton, New Jersey): PMA supplement approved for OPTIMIZER Smart System. Dated 42 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 NJ FdaApprovalPulse records and the 4-column CSV export.
| Field | Value |
|---|---|
| Sponsor | Impulse Dynamics (Usa), Inc. |
| Product | OPTIMIZER Smart System |
| Generic / ingredient | Implantable pulse generator |
| Approval | PMA supplement (device change) |
| Application | P180036 S044 |
| Decided | 2026-09-24 |
| Panel / class | Cardiovascular |
| Sponsor location | Marlton, NJ |
| Peer records CSV (4 NJ records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
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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: 2026-09-24
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
Top FdaApprovalPulse records (NJ first): ETHICON, Inc. · ETHICON, Inc. · ETHICON, 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
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Peer benchmark and outreach value: Impulse Dynamics (Usa), Inc. and 4 New Jersey peers
- New Jersey FdaApprovalPulse records like this one: 4
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every New Jersey peer: $800 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
30 / 100 Score
What is the FdaApprovalPulse record for Impulse Dynamics (Usa), Inc. in Marlton, New Jersey?
The FDA approved OPTIMIZER Smart System (P180036 S044) for Impulse Dynamics (Usa), Inc. on 2026-09-24: PMA supplement (device change).
How does Impulse Dynamics (Usa), Inc. compare to other New Jersey FdaApprovalPulse records?
It is 42 days old, still within a typical 45-day follow-up window. Its Score of 30/100 is modest; treat it as background rather than a priority.
Impulse Dynamics (Usa), Inc. vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Impulse Dynamics (Usa), Inc. | Marlton, NJ | 2026-09-24 |
| 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 |
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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.