INSYNC/ INSYNC III, CRT IPG'S
FDA premarket approval P010015/S027 · decided 2007-05-03
Approval details
- PMA number
- P010015
- Supplement
- S027
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- INSYNC/ INSYNC III, CRT IPG'S
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Medtronic, Inc.
- Date received
- 2007-03-09
- Decision date
- 2007-05-03
- Days to decision
- 55 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR SOFTWARE ENHANCEMENTS TO THE MEDTRONIC MODEL 9986 DESKTOP BOSS (VERSION 1.6) FOR THE MEDTRONIC MODEL 2090 CARELINK PROGRAMMER FOR ALL CURRENTLY APPROVED MEDTRONIC AND VITATRON PACEMAKER AND ICD MODELS.
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