VENTAK P MODELS 1600&1610 & SOFTWARE MODULE 2830
FDA premarket approval P890061/S001 · decided 1992-02-10
Approval details
- PMA number
- P890061
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- VENTAK P MODELS 1600&1610 & SOFTWARE MODULE 2830
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 1991-05-07
- Decision date
- 1992-02-10
- Days to decision
- 279 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.