ALTERNATE STERILIZATION/VENTAK(TM)1550,55 PULSE
FDA premarket approval P830060/S028 · decided 1992-10-30
Approval details
- PMA number
- P830060
- Supplement
- S028
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ALTERNATE STERILIZATION/VENTAK(TM)1550,55 PULSE
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 1991-11-07
- Decision date
- 1992-10-30
- Days to decision
- 358 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.