GEM, JEWEL, MICRO JEWEL, JEWEL PLUS, MICRO JEWEL II PCD
FDA premarket approval P900061/S136 · decided 2015-08-17
Approval details
- PMA number
- P900061
- Supplement
- S136
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- 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
- 2015-07-02
- Decision date
- 2015-08-17
- Days to decision
- 46 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR AN UPDATE TO THE 2090 CARELINK PROGRAMMER DESKTOP SOFTWARE MODEL 9986.
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