MEDTRONICS CARELINK HOME MONITOR AND CARDIOSIGHT READER
FDA premarket approval P890003/S210 · decided 2011-03-17
Approval details
- PMA number
- P890003
- Supplement
- S210
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDTRONICS CARELINK HOME MONITOR AND CARDIOSIGHT READER
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- Medtronic, Inc.
- Date received
- 2010-12-23
- Decision date
- 2011-03-17
- Days to decision
- 84 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR MODIFICATIONS TO THE CARELINK HOME MONITOR MODEL 2490G, DEVICE AND DATA MANAGEMENT APPLICATION MODEL 2491, AND CARDIOSIGHT READER MODEL 2020A.
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