ENDURANT STENT GRAFT SYSTEM, ENDURANT II STENT GRAFT SYSTEM, ENDURANT II AORTO-UNI-LLIAC (AUI) STENT GRAFT SYSTEM
FDA premarket approval P100021/S050 · decided 2015-11-24
Approval details
- PMA number
- P100021
- Supplement
- S050
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ENDURANT STENT GRAFT SYSTEM, ENDURANT II STENT GRAFT SYSTEM, ENDURANT II AORTO-UNI-LLIAC (AUI) STENT GRAFT SYSTEM
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Medtronic Vascular
- Date received
- 2015-10-27
- Decision date
- 2015-11-24
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- IMPLEMENTATION OF AN IN-PROCESS INSPECTION USING AN AUTOMATIC PICK COUNTER DURING THE KITTING PROCESS TO INSPECT THE PICKS PER INCH (PPI) OF THE RECOVERED GRAFT MATERIALS.
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