CARELINK HOME MONITOR MODEL 2490C, CARDIOSIGHT READER MODEL 2020A, CAELINK NETWORK DEVICE
FDA premarket approval P890003/S179 · decided 2012-01-09
Approval details
- PMA number
- P890003
- Supplement
- S179
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CARELINK HOME MONITOR MODEL 2490C, CARDIOSIGHT READER MODEL 2020A, CAELINK NETWORK DEVICE
- Generic name
- Pacemaker/icd/crt non-implanted components
- Applicant
- Medtronic, Inc.
- Date received
- 2009-12-04
- Decision date
- 2012-01-09
- Days to decision
- 766 days
- Decision code
- APPR
- Product code
- OSR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE DF4 CONNECTOR SYSTEM, WHICH IS COMPRISED OF THE ICD, CRT-D AND DEFIBRILLATION LEAD DEVICES FOR THE DEVICES.
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