CARELINK MONITOR MODEL 2490C, MODEL 2491 DDMA AND CARDIOSIGHT READER MODEL 2020A
FDA premarket approval P890003/S150 · decided 2008-10-21
Approval details
- PMA number
- P890003
- Supplement
- S150
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CARELINK MONITOR MODEL 2490C, MODEL 2491 DDMA AND CARDIOSIGHT READER MODEL 2020A
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- Medtronic, Inc.
- Date received
- 2008-09-26
- Decision date
- 2008-10-21
- Days to decision
- 25 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL TO IMPLEMENT A DESIGN CHANGE TO USE MODELS 2490C MEDTRONIC CARELINK MONITOR, 2020A CARDIOSIGHT READER, AND 2491 DEVICE DATA MANAGEMENT APPLICATION (DDMA) TO PROVIDE PATIENTS AND DATA TRANSFER FOR THE CONCERTO II MODEL CRT-D D274TRK, VIRTUOSO II ICD MODEL DR D274DRG AND MODEL VR D274VRC DEVICES.
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