VIGOR(TM) DR PACEMAKER SYSTEM
FDA premarket approval P940031/S004 · decided 1996-10-18
Approval details
- PMA number
- P940031
- Supplement
- S004
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VIGOR(TM) DR PACEMAKER SYSTEM
- Applicant
- Boston Scientific
- Date received
- 1996-01-25
- Decision date
- 1996-10-18
- Days to decision
- 267 days
- Decision code
- APPR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- NEW PULSE GENERATOR MODE THE VIGOR(R) DR FAMILY OF PACEMAKER SYSTEMS
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.