STYLET ACCESSORY KIT
FDA premarket approval P830060/S045 · decided 2000-01-19
Approval details
- PMA number
- P830060
- Supplement
- S045
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- STYLET ACCESSORY KIT
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 1999-08-25
- Decision date
- 2000-01-19
- Days to decision
- 147 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Supplemental approval is for the stylet accessory kit Models 6983 and 6985.
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