Lead Repair Kit Model 6946
FDA premarket approval P910073/S177 · decided 2024-03-28
Approval details
- PMA number
- P910073
- Supplement
- S177
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Lead Repair Kit Model 6946
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2024-03-20
- Decision date
- 2024-03-28
- Days to decision
- 8 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- to replace HP laser printers with five Thermal Transfer Zebra Printers (ZT620), and to replace paper label stock with thermal transfer label stock, for the Lead Repair Kit
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