PMA P120006S013

Device: OVATION AND OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM
Applicant: Endologix, LLC
PMA number: P120006
Supplement: S013
Product code: MIH
Decision date: 2014-12-18
Classification: System, Endovascular Graft, Aortic Aneurysm Treatment
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement: APPROVAL TO CHANGE THE MANUFACTURING PROCESS FOR THE IPSILATERAL TAB ON THE AORTIC BODY STENT GRAFT FROM MANUAL TO AUTOMATED.

Current openFDA PMA Record#

Device: OVATION AND OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM
Applicant: Endologix, LLC
PMA number: P120006
Supplement: S013
Product code: MIH
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date: 2014-12-18
Decision code: APPR
Date received: 2014-04-17
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL TO CHANGE THE MANUFACTURING PROCESS FOR THE IPSILATERAL TAB ON THE AORTIC BODY STENT GRAFT FROM MANUAL TO AUTOMATED.