INSYNC PACEMAKER AND INSYNC III CRT-IPG
FDA premarket approval P010015/S055 · decided 2008-12-11
Approval details
- PMA number
- P010015
- Supplement
- S055
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- INSYNC PACEMAKER AND INSYNC III CRT-IPG
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Medtronic, Inc.
- Date received
- 2008-10-17
- Decision date
- 2008-12-11
- Days to decision
- 55 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR ADDITIONAL CHANGES TO SUPPORT MIGRATION FROM OS/2 TO XPE.
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