INSYNC III
FDA premarket approval P010015/S064 · decided 2009-04-24
Approval details
- PMA number
- P010015
- Supplement
- S064
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- INSYNC III
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Medtronic, Inc.
- Date received
- 2009-02-23
- Decision date
- 2009-04-24
- Days to decision
- 60 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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