INSYNC/INSYNC II CRT-IPG'S
FDA premarket approval P010015/S021 · decided 2006-03-31
Approval details
- PMA number
- P010015
- Supplement
- S021
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- INSYNC/INSYNC II CRT-IPG'S
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Medtronic, Inc.
- Date received
- 2006-02-14
- Decision date
- 2006-03-31
- Days to decision
- 45 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE MEDTRONIC MODEL 9986 DESKTOP/BOSS (SOFTWARE VERSION 1.5.1) FOR THE MEDTRONIC MODEL 2090 CARELINK PROGRAMMER FOR ALL MEDTRONIC PACEMAKER AND ICD MODELS. IT IS TO ENHANCE INTERNAL
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