ACTIVITRAX, ACTIVITRAX II, LEGEND, LEGEND II, MICRO MINIX, MINIX, MINIX ST, PREMIER, PREVAIL,VITATRON LEGACY SR
FDA premarket approval P850051/S084 · decided 2015-08-17
Approval details
- PMA number
- P850051
- Supplement
- S084
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ACTIVITRAX, ACTIVITRAX II, LEGEND, LEGEND II, MICRO MINIX, MINIX, MINIX ST, PREMIER, PREVAIL,VITATRON LEGACY SR
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Medtronic, Inc.
- Date received
- 2015-07-02
- Decision date
- 2015-08-17
- Days to decision
- 46 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR AN UPDATE TO THE 2090 CARELINK PROGRAMMER DESKTOP SOFTWARE MODEL 9986.
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510(k) clearances by this applicant
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