VIGOR(TM) DR PACEMAKER SYSTEM
FDA premarket approval P940031/S001 · decided 1996-02-20
Approval details
- PMA number
- P940031
- Supplement
- S001
- 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
- 1995-06-26
- Decision date
- 1996-02-20
- Days to decision
- 239 days
- Decision code
- APPR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR REPLACING THE CURRENT CONNECTOR TOP MATERIAL FOR THE ABOVE PULSE GENERATOR MODELS, PELLETHANE 2363-75D POLYURETHANE, WITH TECOTHANE TT1075D-M POLYURETHANE
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