PROTECTA CRT-D & PROTECTA XT CRT-D
FDA premarket approval P010031/S443 · decided 2014-06-20
Approval details
- PMA number
- P010031
- Supplement
- S443
- 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
- 2014-04-18
- Decision date
- 2014-06-20
- Days to decision
- 63 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR AN UPDATED VERSION OF THE PROTECTA SOFTWARE, MODEL SW009 USED ON THE 2090 PROGRAMMER AND ENCORE PROGRAMMER MODEL 29901 FOR THE DEVICES.
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