VENTAK P 1600 AICD AND 2830 SOFTWARE MODULE
FDA premarket approval P890061 · decided 1991-05-02
Approval details
- PMA number
- P890061
- Trade name
- VENTAK P 1600 AICD AND 2830 SOFTWARE MODULE
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 1989-11-27
- Decision date
- 1991-05-02
- Days to decision
- 521 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
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