MODEL 6577 STERILIZABLE TELEMETRY WAND
FDA premarket approval P830060/S048 · decided 2000-05-30
Approval details
- PMA number
- P830060
- Supplement
- S048
- Supplement type
- Real-Time Process
- 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
- 2000-04-27
- Decision date
- 2000-05-30
- Days to decision
- 33 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR THE MODEL 6577 STERILIZABLE TELEMETRY WAND.
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