ACE Header, End Cap, Epicardial Patch Lead and Upsizing Sleeve
FDA premarket approval P900061/S152 · decided 2019-03-26
Approval details
- PMA number
- P900061
- Supplement
- S152
- 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
- 2019-02-28
- Decision date
- 2019-03-26
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Update for the use of a new process challenge device.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.