CARELINK MONITOR MODELS 2490C AND 2491 DDMA, CARDIOSIGHT READER MODEL 2020A, CARELINK EXPRESS MONITOR 2020B, MYCARELINK
FDA premarket approval P890003/S354 · decided 2016-10-12
Approval details
- PMA number
- P890003
- Supplement
- S354
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CARELINK MONITOR MODELS 2490C AND 2491 DDMA, CARDIOSIGHT READER MODEL 2020A, CARELINK EXPRESS MONITOR 2020B, MYCARELINK
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- Medtronic, Inc.
- Date received
- 2016-04-15
- Decision date
- 2016-10-12
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for the 1.5T/3T MR Conditional Evera MRI and Visia AF MRI DF-1 ICDs, 1.5T/3T MR Conditional Labeling of approved Sprint Quattro Secure Lead Models 6935 and 6947, and 3T MR Conditional labeling of Visia AF MRI DF4 ICDs.
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