INSYNC III CRT-P
FDA premarket approval P010015/S032 · decided 2008-02-08
Approval details
- PMA number
- P010015
- Supplement
- S032
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- INSYNC III CRT-P
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Medtronic, Inc.
- Date received
- 2007-09-17
- Decision date
- 2008-02-08
- Days to decision
- 144 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR CHANGING THE SURFACTANT USED TO HELP DISPERSE POLYTETRAFLUOROETHY-LENE (PTFE) DURING THE BATTERY MANUFACTURING PROCESS.
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