MODEL 2490G/H/J MEDTRONIC CARELINK MONITOR AND THE MODEL 2020A CARDIOSIGHT READER
FDA premarket approval P900061/S073 · decided 2007-09-11
Approval details
- PMA number
- P900061
- Supplement
- S073
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- MODEL 2490G/H/J MEDTRONIC CARELINK MONITOR AND THE MODEL 2020A CARDIOSIGHT READER
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2007-08-23
- Decision date
- 2007-09-11
- Days to decision
- 19 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR LABELING CHANGES THAT ADD AN INSTRUCTION THAT IS INTENDED TO ENHANCE THE SAFE USE OF THE DEVICE.APPROVAL FOR LABELING CHANGES THAT ADD AN INSTRUCTION THAT IS INTENDED TO ENHANCE THE SAFE USE OF THE DEVICE.
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