VARIOUS INSYNC FAMILIES OF CRT-ICDS
FDA premarket approval P010031/S049 · decided 2007-01-24
Approval details
- PMA number
- P010031
- Supplement
- S049
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- VARIOUS INSYNC FAMILIES OF CRT-ICDS
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2006-08-03
- Decision date
- 2007-01-24
- Days to decision
- 174 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR A CHANGE IN THE ALLOWABLE EXPOSURE LIMIT FOR THE BATTERY AND CAPACITOR AT THE FINAL DEVICE MANUFACTURING SITE.
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