GEM VR MODELS 7227 B/D/E/CX
FDA premarket approval P900061/S047 · decided 2001-10-10
Approval details
- PMA number
- P900061
- Supplement
- S047
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- GEM VR MODELS 7227 B/D/E/CX
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2001-09-07
- Decision date
- 2001-10-10
- Days to decision
- 33 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR MODIFICATIONS TO THE CONNECTOR MODULES AND CONNECTOR ASSEMBLY. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME GEM VR MODELS 7227 B/D/E/CX AND IS INDICATED FOR USE IN PATIENTS WHO ARE AT RISK OF SUDDEN DEATH DUE TO VENTRICULAR ARRHYTHMIAS AND HAVE EXPERIENCED ONE OF THE FOLLOWING SITUATIONS: 1) SURVIVAL OF AT LEAST ONE EPISODE OF A CARDIAC ARREST (MANIFESTED BY LOSS OF CONSCIOUSNESS) DUE TO A VENTRICULAR TACHYARRHYTHMIA 2) RECURRENT, POORLY TOLERATED, SUSTAINED VENTRI
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