Protecta CRT-D and Protectea XT CRT-D
FDA premarket approval P010031/S643 · decided 2018-09-05
Approval details
- PMA number
- P010031
- Supplement
- S643
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Protecta CRT-D and Protectea XT CRT-D
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2018-08-17
- Decision date
- 2018-09-05
- Days to decision
- 19 days
- Decision code
- OK30
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Update the Titan Device Level Final Functional Tester for the Protecta family devices.
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