PMA P120006S026
- Device
- OVATION ABDOMINAL STENT GRAFT SYSTEM PLATFORM
- Applicant
- Endologix, LLC
- PMA number
- P120006
- Supplement
- S026
- Product code
- MIH
- Decision date
- 2016-08-24
- Classification
- System, Endovascular Graft, Aortic Aneurysm Treatment
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- Implementation of an update to the iliac stent graft sheath loading fixture configuration and a revision to the corresponding loading process instructions to include the updated fixture configuration; 2) Implementation of the modified maximum loading force specification and in-sheath force specification of the Ovation iX Iliac Limb Stent Graft; and3) Implementation of the modified crimp diameter for the 14 mm Ovation iX Iliac Stent Graft.
Current openFDA PMA Record#
- Device
- OVATION ABDOMINAL STENT GRAFT SYSTEM PLATFORM
- Applicant
- Endologix, LLC
- PMA number
- P120006
- Supplement
- S026
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2016-08-24
- Decision code
- OK30
- Date received
- 2016-07-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implementation of an update to the iliac stent graft sheath loading fixture configuration and a revision to the corresponding loading process instructions to include the updated fixture configuration; 2) Implementation of the modified maximum loading force specification and in-sheath force specification of the Ovation iX Iliac Limb Stent Graft; and3) Implementation of the modified crimp diameter for the 14 mm Ovation iX Iliac Stent Graft.