MODEL 2490A CARELINK MONITOR AND 2491 SOFTWARE
FDA premarket approval P980016/S021 · decided 2001-12-21
Approval details
- PMA number
- P980016
- Supplement
- S021
- Supplement type
- Normal 180 Day Track
- Trade name
- MODEL 2490A CARELINK MONITOR AND 2491 SOFTWARE
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2001-09-06
- Decision date
- 2001-12-21
- Days to decision
- 106 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE MODEL 2490A CARELINK MONITOR WITH MODEL 2491 DDMA SERVER-RESIDENT SOFTWARE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MODEL 2490A CARELINK MONITOR AND IS INDICATED FOR USE IN THE TRANSFER OF PATIENT DATA FROM MEDTRONIC GEM II ICDS (GEM II VR MODEL 7229 AND GEM II DR MODEL 7273).
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