PMA P120006S005
- Device
- OVATION AND OVATION PRIME ABDOMINAL STENT GRAFT SYSTEMS
- Applicant
- Endologix, LLC
- PMA number
- P120006
- Supplement
- S005
- Product code
- MIH
- Decision date
- 2014-03-26
- Classification
- System, Endovascular Graft, Aortic Aneurysm Treatment
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- APPROVAL FOR AN ALTERNATE DELIVERY SYSTEM SHEATH SUPPLIER.
Current openFDA PMA Record#
- Device
- OVATION AND OVATION PRIME ABDOMINAL STENT GRAFT SYSTEMS
- Applicant
- Endologix, LLC
- PMA number
- P120006
- Supplement
- S005
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2014-03-26
- Decision code
- APPR
- Date received
- 2013-08-12
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR AN ALTERNATE DELIVERY SYSTEM SHEATH SUPPLIER.