CARELINK MONITORS, MODELS 2490G AND 2490J
FDA premarket approval P890003/S084 · decided 2006-01-24
Approval details
- PMA number
- P890003
- Supplement
- S084
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Express GMP Supplement
- Trade name
- CARELINK MONITORS, MODELS 2490G AND 2490J
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- Medtronic, Inc.
- Date received
- 2005-04-15
- Decision date
- 2006-01-24
- Days to decision
- 284 days
- Decision code
- APPR
- Product code
- NVZ
- 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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