FDA.reportPublic FDA data

PMA P120006S024

Device
OVATION ABDOMINAL STENT GRAFT SYSTEM
Applicant
Endologix, LLC
PMA number
P120006
Supplement
S024
Product code
MIH
Decision date
2016-09-29
Classification
System, Endovascular Graft, Aortic Aneurysm Treatment
Generic name
SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement
Approval for manufacturing sites located at Synergy Health AST, LLC, 9020 Activity Road Suite D, San Diego, California 92126 and Synergy Health AST, LLC, 3200 Lakeville Highway, Suite 120, Petaluma, California 94954, for E-Beam sterilization of the Ovation Abdominal Stent Graft System Platform.

Current openFDA PMA Record#

Device
OVATION ABDOMINAL STENT GRAFT SYSTEM
Applicant
Endologix, LLC
PMA number
P120006
Supplement
S024
Product code
MIH
Generic name
SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date
2016-09-29
Decision code
APPR
Date received
2016-03-18
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Approval for manufacturing sites located at Synergy Health AST, LLC, 9020 Activity Road Suite D, San Diego, California 92126 and Synergy Health AST, LLC, 3200 Lakeville Highway, Suite 120, Petaluma, California 94954, for E-Beam sterilization of the Ovation Abdominal Stent Graft System Platform.