GEM, JEWEL, MICRO JEWEL, JEWEL PLUS, MICRO JEWEL II, PCD
FDA premarket approval P900061/S114 · decided 2012-04-25
Approval details
- PMA number
- P900061
- Supplement
- S114
- Supplement type
- Real-Time Process
- Trade name
- GEM, JEWEL, MICRO JEWEL, JEWEL PLUS, MICRO JEWEL II, PCD
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2012-04-04
- Decision date
- 2012-04-25
- Days to decision
- 21 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR SOFTWARE UPDATES AND MINOR SOFTWARE ENHANCEMENTS TO MEDTRONIC MODEL 9986 DESKTOP/ BASELINE OPERATING SYSTEM SOFTWARE (BOSS) VERSION 2.6 FOR THE MEDTRONIC MODEL 2090 CARELINK PROGRAMMER.
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