GEM DR/GEM II DR/GEM II VR
FDA premarket approval P980016/S018 · decided 2001-05-14
Approval details
- PMA number
- P980016
- Supplement
- S018
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- GEM DR/GEM II DR/GEM II VR
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2001-04-17
- Decision date
- 2001-05-14
- Days to decision
- 27 days
- Decision code
- APPR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE GENERAL USE INDICATION FOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR MODELS MICRO JEWEL 7221, MICRO JEWEL II 7223, GEM DR 7271, GEM II DR 7273 AND GEM II VR 7229 AND ARE INDICATED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE THREATENING VENTRICULAR ARRHYTHMIAS.
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