MEDTRONIC CARELINK EXPRESS MONITORS, MODIFICATIONS T THE MEDTRONIC CARELINK REMOTE HOME MONITOR AND MEDTRONIC CARDIOSIGH
FDA premarket approval P890003/S228 · decided 2011-08-25
Approval details
- PMA number
- P890003
- Supplement
- S228
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDTRONIC CARELINK EXPRESS MONITORS, MODIFICATIONS T THE MEDTRONIC CARELINK REMOTE HOME MONITOR AND MEDTRONIC CARDIOSIGH
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- Medtronic, Inc.
- Date received
- 2011-05-25
- Decision date
- 2011-08-25
- Days to decision
- 92 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR MODELS 2020B/C MEDTRONIC CARELINK EXPRESS MONITORS AND MODIFICATIONS TO THE MODEL 2490/G/H/J MEDTRONIC CARELINK REMOTE HOME MONITOR AND MODEL 2020A MEDTRONIC CARDIOSIGHT READER TO UPDATE DEVICE FIRMWARE.
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