PMA P990020S043

Device: ANEURX AAADVANTAGE STENT GRAFT
Applicant: Medtronic Vascular
PMA number: P990020
Supplement: S043
Product code: MIH
Decision date: 2011-04-12
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement: APPROVAL TO EXTEND THE SCOPE OF THE RECEIVING AND MANUFACTURING ACTIVITIES CONDUCTED AT A THIRD PARTY STORAGE LOCATION.

Current openFDA PMA Record

Device: ANEURX AAADVANTAGE STENT GRAFT
Applicant: Medtronic Vascular
PMA number: P990020
Supplement: S043
Product code: MIH
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date: 2011-04-12
Decision code: APPR
Date received: 2010-12-10
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL TO EXTEND THE SCOPE OF THE RECEIVING AND MANUFACTURING ACTIVITIES CONDUCTED AT A THIRD PARTY STORAGE LOCATION.