INSYNC CRT-P/INSYNC III CRT-P
FDA premarket approval P010015/S076 · decided 2010-02-18
Approval details
- PMA number
- P010015
- Supplement
- S076
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- INSYNC CRT-P/INSYNC III CRT-P
- Generic name
- Drug eluting permanent left ventricular (lv) pacemaker electrode
- Applicant
- Medtronic, Inc.
- Date received
- 2010-01-13
- Decision date
- 2010-02-18
- Days to decision
- 36 days
- Decision code
- OK30
- Product code
- OJX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- UPDATED VERSION OF THE SOFTWARE FOR THE FEEDTHROUGH LASER WELDER.
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