ENDURANT II STENT GRAFT SYSTEM, ENDURANT IIS STENT GRAFT SYSTEM
FDA premarket approval P100021/S047 · decided 2015-05-06
Approval details
- PMA number
- P100021
- Supplement
- S047
- Supplement type
- Special (Immediate Track)
- Trade name
- ENDURANT II STENT GRAFT SYSTEM, ENDURANT IIS STENT GRAFT SYSTEM
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Medtronic Vascular
- Date received
- 2015-04-14
- Decision date
- 2015-05-06
- Days to decision
- 22 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- APPROVAL FOR INTRODUCING A LAMP MANDREL AS A MANUFACTURING TOOL FOR THE INSPECTION OF THE RADIOPAQUE CONTRALATERAL GATE MARKER DURING THE MARKER ATTACHMENT PROCESS.
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