CARELINK HOME MONITOR AND CARDIOSIGHT MONITOR
FDA premarket approval P890003/S209 · decided 2011-05-04
Approval details
- PMA number
- P890003
- Supplement
- S209
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CARELINK HOME MONITOR AND CARDIOSIGHT MONITOR
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- Medtronic, Inc.
- Date received
- 2010-12-22
- Decision date
- 2011-05-04
- Days to decision
- 133 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR UPDATES TO MEDTRONIC¿S REVEAL 2090 APPLICATION SOFTWARE MODEL SW007 FOR USE WITH THE MEDTRONIC REVEAL IMPLANTABLE CARDIAC MONITOR (ICM) SYSTEM.
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