VIGOR DR PACEMAKER SYSTEM; VIGOR DR MODEL 1230
FDA premarket approval P940031/S002 · decided 1996-02-26
Approval details
- PMA number
- P940031
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VIGOR DR PACEMAKER SYSTEM; VIGOR DR MODEL 1230
- Applicant
- Boston Scientific
- Date received
- 1995-08-09
- Decision date
- 1996-02-26
- Days to decision
- 201 days
- Decision code
- APPR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR ADDING AN ALTERNATE LOWER PROFILE CONNECTOR TOP FOR THE VIGOR DR MODEL 1230 PACEMAKERS
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