CARELINK PROGRAMMER (MODEL 2090)/ANALYZER (MODEL 2290)
FDA premarket approval P890003/S086 · decided 2005-09-28
Approval details
- PMA number
- P890003
- Supplement
- S086
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CARELINK PROGRAMMER (MODEL 2090)/ANALYZER (MODEL 2290)
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- Medtronic, Inc.
- Date received
- 2005-05-06
- Decision date
- 2005-09-28
- Days to decision
- 145 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR "SOFTWARE ENHANCEMENTS" TO THE MODEL 9986 DESKTOP/BASELINE OPERATING SYSTEM SOFTWARE (BOSS) FOR THE CARELINK PROGRAMMER AND THE MODEL 8190 ANALYZER SOFTWARE FOR THE MODEL 2290 ANALYZER.
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