EPICARDIAL TRANSVENE/CABLE/ACE HEADER/UPSIZING SLEEVE FOR HV LEAD DF-1/UPSIZING SLEEVE/LEAD END PIN CAP
FDA premarket approval P900061/S081 · decided 2009-01-09
Approval details
- PMA number
- P900061
- Supplement
- S081
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- EPICARDIAL TRANSVENE/CABLE/ACE HEADER/UPSIZING SLEEVE FOR HV LEAD DF-1/UPSIZING SLEEVE/LEAD END PIN CAP
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2008-12-11
- Decision date
- 2009-01-09
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- CHANGE IN THE STERILIZATION PROCESS.
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