DELTA PACEMAKER SYSTRM; VIGOR DDD MODEL 950 (MASTER)
FDA premarket approval P840068/S027 · decided 1996-03-12
Approval details
- PMA number
- P840068
- Supplement
- S027
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- DELTA PACEMAKER SYSTRM; VIGOR DDD MODEL 950 (MASTER)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 1995-08-09
- Decision date
- 1996-03-12
- Days to decision
- 216 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APRPOVAL FOR ADDING AN ALTERNATE LOWER PROFILE CONNECTOR TOP FOR THE VIGOR DDD MODEL 950 PACEMAKER
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.