MEDTRONIC MODEL 2090 CARELINK PROGRAMMER WITH TELEMETRY C
FDA premarket approval P890003/S080 · decided 2005-02-18
Approval details
- PMA number
- P890003
- Supplement
- S080
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDTRONIC MODEL 2090 CARELINK PROGRAMMER WITH TELEMETRY C
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- Medtronic, Inc.
- Date received
- 2004-12-06
- Decision date
- 2005-02-18
- Days to decision
- 74 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE ADDITION OF DISTANCE TELEMETRY FUNCTIONALITY TO THE CURRENTLY APPROVED PROGRAMMER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MEDTRONIC MODEL 2090 CARELINK PROGRAMMER WITH TELEMETRY C AND IS INDICATED FOR USE IN THE INTERROGATION AND PROGRAMMING OF IMPLANTABLE MEDICAL DEVICES.
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