VIGOR(R) DR/SR PACEMAKER SYSTEM
FDA premarket approval P940031/S009 · decided 1997-02-18
Approval details
- PMA number
- P940031
- Supplement
- S009
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VIGOR(R) DR/SR PACEMAKER SYSTEM
- Applicant
- Boston Scientific
- Date received
- 1996-12-23
- Decision date
- 1997-02-18
- Days to decision
- 57 days
- Decision code
- APPR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FORT HE MODIFICATION OF THE DIAGNOSTIC (SELF-TEST) FUNCTION OF THE MDOEL 2909 MULTIPLE APPLICATION UTILITY (MAU) TO ACCOMMODATE VARIABILITY IN WATCH DOG TIMER (WDT) TIME-OUT PERIODS.
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