End Cap, Epicardial Patch Lead, Sizing Sleeve
FDA premarket approval P900061/S174 · decided 2024-11-13
Approval details
- PMA number
- P900061
- Supplement
- S174
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- End Cap, Epicardial Patch Lead, Sizing Sleeve
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2024-10-17
- Decision date
- 2024-11-13
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- to update the manufacturing execution system to FACTORYworks Release 10.0
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