VIGOR(TM) DR PACEMAKER SYSTEM
FDA premarket approval P940031/S003 · decided 1996-03-21
Approval details
- PMA number
- P940031
- Supplement
- S003
- 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
- 1995-09-11
- Decision date
- 1996-03-21
- Days to decision
- 192 days
- Decision code
- APPR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR THE USE OF THE VIGOR MODEL 2880 SOFTWARE APPLICATION USED IN CONJUNCTION WITH THE MODEL 2909 MULTIPLE APPLICATIO UTILITY (MAU) ON THE MODEL 2950 PRM FOR PROGRAMMING OF ALL COMMERCIALLY AVAILABLE VIGRO PACEMAKERS
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