CARELINK MONITORS, MODELS 2490G AND 2490J
FDA premarket approval P010031/S022 · decided 2006-01-24
Approval details
- PMA number
- P010031
- Supplement
- S022
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Express GMP Supplement
- Trade name
- CARELINK MONITORS, MODELS 2490G AND 2490J
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2005-04-15
- Decision date
- 2006-01-24
- Days to decision
- 284 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT TRIVIRIX MINNEAPOLIS, INC., MILACA, MINNESOTA, FOR THE FINAL TESTING, LABELING AND PACKAGING OF THE DEVICE.
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