INSYNC MAXIMO MODEL 7303 ONYX VR
FDA premarket approval P980016/S047 · decided 2005-03-31
Approval details
- PMA number
- P980016
- Supplement
- S047
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- INSYNC MAXIMO MODEL 7303 ONYX VR
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2005-01-21
- Decision date
- 2005-03-31
- Days to decision
- 69 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE MODELS 2490G AND 2490J CARELINK MONITORS AND MODEL 2491 DDMA SOFTWARE FOR USE WITH THE INSYNC SENTRY MODEL 7297, INSYNC II PROTECT MODEL 7295, INSYNC MAXIMO MODEL 7303, ONYX VR MODEL 7290CX, INTRINSIC 30 MODEL 7287 AND INTRINSIC MODEL 7288 IMPLANTABLE DEVICES. THE CARELINK SYSTEM IS INDICATED FOR USE BY A PATIENT TO INTERROGATE THEIR IMPLANTED DEVICE, AND TRANSFER THE DATA TO A PRIVATE, SECURE SERVER BY USE OF A STANDARD (ANALOG) TELEPHONE CONNECTION.
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