Ventak P2 AICD Model 1625 and Ventak P3 AICD Models 1630 and 1635 - 1635
PMA P930035
Active
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP930035 | Date10 Mar 1995 | StatusActive |
Official records
- FDA PMA database P930035
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Trade name
- Ventak(R) P2 System
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- PMA number
- FDA product code
- LWS
- Models / Variants
- 1635
- Device class
- Class III
- Advisory committee
- Cardiovascular
- FDA decision
- APPR Approved
Overview
AI-generated summary, 18 Sep 2026
The Ventak P2 AICD Model 1625 and Ventak P3 AICD Models 1630 and 1635 are implantable cardioverter defibrillators (non-CRT) designed to monitor and treat life-threatening cardiac arrhythmias. These devices automatically detect and respond to dangerous heart rhythms, such as ventricular tachycardia or ventricular fibrillation, by delivering appropriate electrical shocks or pacing therapies to restore a normal heart rhythm.
These devices are implanted surgically and are intended for single-use, though they may be replaced or upgraded as medical needs evolve. Authorized under FDA PMA (P930035), they are classified as Class III medical devices and require professional installation and maintenance in clinical settings. Compliance with regulatory standards ensures safe and effective use in cardiac care environments.
Devices cleared under P930035
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| 6501 | 6501 | 00802526489228 | — | On the market |
| 6501 | 666501-105 / 6501 | 00802526605901 | — | On the market |