MODEL 6888 LEAD TUNNELER ACCESSORY
FDA premarket approval P830060/S040 · decided 1995-10-03
Approval details
- PMA number
- P830060
- Supplement
- S040
- Supplement type
- Normal 180 Day Track
- Trade name
- MODEL 6888 LEAD TUNNELER ACCESSORY
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 1995-02-10
- Decision date
- 1995-10-03
- Days to decision
- 235 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR CPI MODEL 6888 LEAD TUNNELER
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