Ventak P2 AICD Model 1625 and Ventak P3 AICD Models 1630 and 1635
PMA P930035
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP930035 | Date10 Mar 1995 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Full name
- Ventak P2 Aicd Model 1625 & Ventak P3 Aicd Models 1630 and 1635
- Trade name
- Ventak(R) P2 System
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- PMA number
- FDA product code
- LWS
- Models / Variants
- 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.
Other devices from Boston Scientific
Questions
AI-generated answers, 18 Sep 2026
What types of life-threatening heart rhythms are these devices designed to treat, and how do they respond to them?
The Ventak P2 (Model 1625) and Ventak P3 (Models 1630 & 1635) are implantable cardioverter defibrillators (non-CRT) that automatically detect and treat ventricular tachycardia or ventricular fibrillation—two dangerous heart rhythms that can lead to sudden cardiac death. When these rhythms are detected, the device delivers appropriate electrical shocks or pacing therapies to restore a normal heart rhythm, ensuring immediate intervention without manual intervention.
Are these devices reusable, or are they intended for single-use only?
While the Ventak P2 and P3 devices are technically implanted surgically, they are not designed for reuse. Instead, they are intended for single-use in a patient, though they may be replaced or upgraded later if clinical needs change or the device requires servicing. Replacement is standard practice in cardiac care to ensure continued reliability and safety.
How are these devices supplied, and what should clinicians consider during storage?
The Ventak P2 and P3 devices are sterile, single-use implants supplied in sterile packaging for surgical implantation. Since they are implanted directly into the body, clinicians must adhere to strict sterile procedures during handling and insertion. Storage should follow manufacturer guidelines to maintain sterility and functionality, typically in a clean, controlled environment away from extreme temperatures or moisture.
What regulatory pathway was followed for FDA authorization, and what does this mean for clinicians?
These devices were authorized through the FDA Premarket Approval (PMA) process under PMA number P930035, a rigorous review for high-risk Class III devices. This means the FDA evaluated extensive clinical data to confirm safety and effectiveness before approval. Clinicians can rely on this pathway as evidence of thorough regulatory scrutiny, ensuring these devices meet stringent standards for treating life-threatening arrhythmias in clinical settings.