MEDTRONIC PROTECTA XT DR D314DRM, PROTECTA DR D334DRM, CARDIOVERTER DEFIBRILLATORS
FDA premarket approval P980016/S218 · decided 2011-11-09
Approval details
- PMA number
- P980016
- Supplement
- S218
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDTRONIC PROTECTA XT DR D314DRM, PROTECTA DR D334DRM, CARDIOVERTER DEFIBRILLATORS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2009-12-23
- Decision date
- 2011-11-09
- Days to decision
- 686 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE PROTECTA XT CRT-D, D314TRM AND PROTECTA CRT-DD334TRM IMPLANTABLE CARDIOVERTCR DEFIBRILLATORS WITH CARDIAC RCSYNCHRONIZATION, PROTECTA XT DR D314DRM AND PROTECTA DR D334DRM IMPLANTABLE CARDIOVERTER DEFIBRILLAIORS, MODEL SW009 APPLICATION SOFTWARE VL.0, CARELINK MONITOR MODEL 2490C UPGRADE. CARDIOSIGHT READER MODEL 2020A UPGRADE AND MODEL 2491 DDMA UPGRADE.
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