ENDURANT STENT GRAFT SYSTEMS
FDA premarket approval P100021/S014 · decided 2012-04-23
Approval details
- PMA number
- P100021
- Supplement
- S014
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ENDURANT STENT GRAFT SYSTEMS
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Medtronic Vascular
- Date received
- 2012-03-22
- Decision date
- 2012-04-23
- Days to decision
- 32 days
- Decision code
- OK30
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- AUTOMATION OF THE ETCHING AND HEAT SETTING PROCESSES AND A CHANGE IN SOLUTION MIXING LOCATION AT A COMPONENT SUPPLIER.
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