Lead Repair Kit Model 6946
FDA premarket approval P910073/S174 · decided 2023-10-24
Approval details
- PMA number
- P910073
- Supplement
- S174
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Lead Repair Kit Model 6946
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2023-08-04
- Decision date
- 2023-10-24
- Days to decision
- 81 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- approval for packaging and component changes to the Lead Repair Kit Model 6946
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