GEM, PCD, & VARIOUS FAMILIES/MODELS OF JEWEL
FDA premarket approval P900061/S110 · decided 2011-11-17
Approval details
- PMA number
- P900061
- Supplement
- S110
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- GEM, PCD, & VARIOUS FAMILIES/MODELS OF JEWEL
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2011-09-19
- Decision date
- 2011-11-17
- Days to decision
- 59 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR AN UPDATE TO THE OPERATING SYSTEM SOFTWARE FOR THE CARELINK PROGRAMMER ASSOCIATED WITH MEDTRONIC PACEMAKER, IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), AND CARDIAC RESYNCHRONIZATION THERAPY (CRT) DEVICES APPROVED UNDER THE REFERENCED PMA.
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