PROTECTA XT CRT-D AND PROTECTA CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATORS WITH CARDIAC RESYNCHRONIZATION; MODEL SW009
FDA premarket approval P010031/S171 · decided 2011-03-25
Approval details
- PMA number
- P010031
- Supplement
- S171
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PROTECTA XT CRT-D AND PROTECTA CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATORS WITH CARDIAC RESYNCHRONIZATION; MODEL SW009
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2009-10-22
- Decision date
- 2011-03-25
- Days to decision
- 519 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR PROTECTA XT CRT-D D314TRG AND PROTECTA CRT-D D334TRG IMPLANTABLE CARDIOVERTER DEFIBRILLATORS WITH CARDIAC RESYNCHRONIZATION, PROTECTA XT DR D314DRG, PROTECTA XT VR D314VRG, PROTECTA DR D334DRG, AND PROTECTA VR D334VRG IMPLANTABLE CARDIOVERTER DEFIBRILLATORS, MODEL SW009 APPLICATION SOFTWARE V1.0, CARELINK MONITOR MODEL 2490C UPGRADE, CARDIOSIGHT READER MODEL 2020A UPGRADE, AND MODEL 2491 DDMA UPGRADE.
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