GEM,JEWEL,MOCRO JEWEL,JEWEL PLUS,MICRO JEWEL II,PCD
FDA premarket approval P900061/S121 · decided 2013-06-11
Approval details
- PMA number
- P900061
- Supplement
- S121
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- GEM,JEWEL,MOCRO JEWEL,JEWEL PLUS,MICRO JEWEL II,PCD
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2013-04-18
- Decision date
- 2013-06-11
- Days to decision
- 54 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR ENHANCEMENTS TO MODEL 9986 DESKTOP/BOSS FOR USE ON THE MODEL 2090 MEDTRONIC CARELINK PROGRAMMER FOR THE DEVICES.
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