PMA P100021S108

Device: Endurant Stent Graft System, Endurant II Stent Graft System, Endurant II AUI Stent Graft System, Talent Endoluminal Occl
Applicant: Medtronic Vascular
PMA number: P100021
Supplement: S108
Product code: MIH
Decision date: 2022-11-01
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement: Automation of a verification step undertaken by Sterile Release Personnel (SRP) for Limulus amebocyte lysate (LAL) Bacterial Endotoxin Testing (BET) prior to final release of product.

Current openFDA PMA Record#

Device: Endurant Stent Graft System, Endurant II Stent Graft System, Endurant II AUI Stent Graft System, Talent Endoluminal Occl
Applicant: Medtronic Vascular
PMA number: P100021
Supplement: S108
Product code: MIH
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date: 2022-11-01
Decision code: OK30
Date received: 2022-10-31
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Automation of a verification step undertaken by Sterile Release Personnel (SRP) for Limulus amebocyte lysate (LAL) Bacterial Endotoxin Testing (BET) prior to final release of product.