Ace Header, End Cap, Epicardial Patch Lead and Upsizing Sleeve
FDA premarket approval P900061/S155 · decided 2019-09-27
Approval details
- PMA number
- P900061
- Supplement
- S155
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Ace Header, End Cap, Epicardial Patch Lead and Upsizing Sleeve
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2019-09-16
- Decision date
- 2019-09-27
- Days to decision
- 11 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Transfer of receiving and incoming inspection activities from Medtronic Rice Creek facility to the Medtronic Puerto Rico Operations Company (MPROC) Villalba, MPROC Juncos, and the Federal Express/Third Party Logistics facility in Guaynabo, Puerto Rico.
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