CARELINK MONITOR MODEL 2490C, MODEL 2491 DDMA AND CARDIOSIGHT READER MODEL 2020A
FDA premarket approval P890003/S148 · decided 2008-10-14
Approval details
- PMA number
- P890003
- Supplement
- S148
- 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
- 2008-08-28
- Decision date
- 2008-10-14
- Days to decision
- 47 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR AN UPDATE (VERSION 1.1) TO SOFTWARE APPLICATION MODEL SW007 FOR THE MEDTRONIC CARELINK PROGRAMMER MODEL 2090.
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