CARELINK MONITOR MODELS 2490G, 2490H AND 2490J
FDA premarket approval P890003/S079 · decided 2005-02-15
Approval details
- PMA number
- P890003
- Supplement
- S079
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Express GMP Supplement
- Trade name
- CARELINK MONITOR MODELS 2490G, 2490H AND 2490J
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- Medtronic, Inc.
- Date received
- 2004-11-01
- Decision date
- 2005-02-15
- Days to decision
- 106 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT PLEXUS SERVICES CORPORATION, BOTHELL, WASHINGTON.
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