VENTAK(R) P MODEL 1600
FDA premarket approval P890061/S012 · decided 1996-11-12
Approval details
- PMA number
- P890061
- Supplement
- S012
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- VENTAK(R) P MODEL 1600
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 1996-10-16
- Decision date
- 1996-11-12
- Days to decision
- 27 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- ALTERNATE STERILIZATION FACILITY LOCATED AT COSMED OF ILLINOIS, 1160 NORTHPOINT BLVD., WAUKEGAN, IL 60085 - THIS SUPPLEMENT REVIEWED UNDER THE SUPPLEMENT PILOT PROGRAM - THIS APPROVAL APPLIES ONLY TO THE NEW STERILIZATION SITE REQUEST
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.