CPI MODEL 6826 & 6828 AICD LEAD STYLET
FDA premarket approval P830060/S023 · decided 1990-10-31
Approval details
- PMA number
- P830060
- Supplement
- S023
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CPI MODEL 6826 & 6828 AICD LEAD STYLET
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 1990-09-27
- Decision date
- 1990-10-31
- Days to decision
- 34 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
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