GEM, GEM II, GEM III, INTRINSIC, MARQUIS, MAXIMO, MAXIMO II, ONYX, PROTECTA, SECURA, VIRTUOSO, VITUOSO II, ENTRUST
FDA premarket approval P980016/S347 · decided 2012-04-25
Approval details
- PMA number
- P980016
- Supplement
- S347
- Supplement type
- Real-Time Process
- Trade name
- GEM, GEM II, GEM III, INTRINSIC, MARQUIS, MAXIMO, MAXIMO II, ONYX, PROTECTA, SECURA, VIRTUOSO, VITUOSO II, ENTRUST
- 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 TOMEDTRONIC MODEL 9986 DESKTOP/ BASELINE OPERATING SYSTEM SOFTWARE (BOSS) VERSION 2.6 FOR THE MEDTRONIC MODEL 2090 CARELINK PROGRAMMER.
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