ENDURANT IIS STENT GRAFT SYSTEM
FDA premarket approval P100021/S042 · decided 2014-11-25
Approval details
- PMA number
- P100021
- Supplement
- S042
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ENDURANT IIS STENT GRAFT SYSTEM
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Medtronic Vascular
- Date received
- 2014-11-07
- Decision date
- 2014-11-25
- Days to decision
- 18 days
- Decision code
- OK30
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- ADDITION OF AN ALTERNATE SUPPLIER FOR THE SECONDARY AND TERTIARY PACKAGINGFOR ENDURANT IIS STENT GRAFT SYSTEMS, AS WELL AS A CHANGE IN CONFIGURATION FOR THE E-BEAM STERILIZATION PROCESS.
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