MODEL 6577 STERILIZABLE TELEMETRY WAND
FDA premarket approval P890061/S002 · decided 1991-11-26
Approval details
- PMA number
- P890061
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MODEL 6577 STERILIZABLE TELEMETRY WAND
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 1991-07-05
- Decision date
- 1991-11-26
- Days to decision
- 144 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
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