Protecta CRT-D, Protecta XT CRT-D
FDA premarket approval P010031/S637 · decided 2018-08-10
Approval details
- PMA number
- P010031
- Supplement
- S637
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Protecta CRT-D, Protecta XT CRT-D
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2018-06-07
- Decision date
- 2018-08-10
- Days to decision
- 64 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for an alternate Defibrillation Controller Integrated Circuit used in Protecta families of ICDs and CRT-Ds.
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