PMA P120006S019
- Device
- OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM, OVATION IX ILIAC STENT GRAFT
- Applicant
- Endologix, LLC
- PMA number
- P120006
- Supplement
- S019
- Product code
- MIH
- Decision date
- 2015-05-21
- Classification
- System, Endovascular Graft, Aortic Aneurysm Treatment
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- APPROVAL FOR MODIFICATIONS TO THE OUTER DIAMETERS OF THE COMPRESSIONSLEEVES.
Current openFDA PMA Record#
- Device
- OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM, OVATION IX ILIAC STENT GRAFT
- Applicant
- Endologix, LLC
- PMA number
- P120006
- Supplement
- S019
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2015-05-21
- Decision code
- APPR
- Date received
- 2015-04-01
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR MODIFICATIONS TO THE OUTER DIAMETERS OF THE COMPRESSIONSLEEVES.