PMA P120006S021
- Device
- OVATION ABDOMINAL STENT GRAFT SYSTEM, OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM, OVATION IX ILIAC STENT GRAFT
- Applicant
- Endologix, LLC
- PMA number
- P120006
- Supplement
- S021
- Product code
- MIH
- Decision date
- 2015-08-07
- Classification
- System, Endovascular Graft, Aortic Aneurysm Treatment
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- CHANGE TO THE PYROGEN SAMPLING PLAN FOR FINISHED PRODUCT RELEASE OF ETHYLENE OXIDE (EO) STERILIZED PRODUCT IN THE OVATION STENT GRAFT/DELIVERY SYSTEM FAMILY.
Current openFDA PMA Record#
- Device
- OVATION ABDOMINAL STENT GRAFT SYSTEM, OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM, OVATION IX ILIAC STENT GRAFT
- Applicant
- Endologix, LLC
- PMA number
- P120006
- Supplement
- S021
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2015-08-07
- Decision code
- OK30
- Date received
- 2015-07-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO THE PYROGEN SAMPLING PLAN FOR FINISHED PRODUCT RELEASE OF ETHYLENE OXIDE (EO) STERILIZED PRODUCT IN THE OVATION STENT GRAFT/DELIVERY SYSTEM FAMILY.