SPRINT QUATTRO LEAD
FDA premarket approval P920015/S047 · decided 2008-08-08
Approval details
- PMA number
- P920015
- Supplement
- S047
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SPRINT QUATTRO LEAD
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic, Inc.
- Date received
- 2008-07-09
- Decision date
- 2008-08-08
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- CHANGES IN THE FOLLOWING AREAS: 1) A CHANGE IN THE CHART RECORDER TO MONITOR THE STERILIZATION PROCESS; 2) A CHANGE IN ETHYLENE OXIDE (EO) STERILIZATION EXPOSURE TIME; AND 3) A CHANGE IN THE INSPECTION METHOD OF THE COATING ON THE INNER DIAMETER OF THE TUBING COMPONENT.
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