PMA P120006S015
- Device
- TRIVASCULAR, INC OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM, TRIVASCULAR, INC OVATION IX ILIAC STENT GRAFT
- Applicant
- Endologix, LLC
- PMA number
- P120006
- Supplement
- S015
- Product code
- MIH
- Decision date
- 2015-02-02
- Classification
- System, Endovascular Graft, Aortic Aneurysm Treatment
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- APPROVAL THE TO ADD A LARGER DIAMETER ILIAC LIMB AND ILIAC EXTENSION, A LONGERLENGTH ILIAC LIMB, AND DECREASE THE DELIVERY SYSTEM PROFILE FOR EACH ILIAC LIMB AND ILIAC EXTENSIONS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME OVATION PRIMEABDOMINAL STENT GRAFT SYSTEM WITH THE OVATION IX ILIAC STENT GRAFT AND IS INDICATED FOR THETREATMENT OF PATIENTS WITH ABDOMINAL AORTIC ANEURYSMS HAVING THE VASCULAR MORPHOLOGY SUITABLEFOR ENDOVASCULAR REPAIR, INCLUDING:1) ADEQUATEILIAC/FEMORAL ACCESS COMPATIBLE WITH VASCULAR ACCESS TECHNIQUES (FEMORALCUTDOWN OR PERCUTANEOUS), DEVICES AND/OR ACCESSORIES;2) PROXIMAL AORTIC LANDING ZONE:A) WITH AN INNER WALL DIAMETER OF NO LESS THAN 16 MM AND NO GREATER THAN 30 MM AT 13MM BELOW THE INFERIOR RENAL ARTERY, AND B) WITH AN AORTIC ANGLE OF < 60 DEGREES IF PROXIMAL NECK IS 10 ¿ MM DEGREES IF PROXIMAL NECK IS < 10 MM; AND 3) DISTAL ILIAC LANDING ZONE:A) WITH A LENGTH OF AT LEAST 10 MM, ANDB) WITH AN INNER WALL DIAMETER OF NO LESS THAN 8 MM AND NO GREATER THAN 25 MM.
Current openFDA PMA Record#
- Device
- TRIVASCULAR, INC OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM, TRIVASCULAR, INC OVATION IX ILIAC STENT GRAFT
- Applicant
- Endologix, LLC
- PMA number
- P120006
- Supplement
- S015
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2015-02-02
- Decision code
- APPR
- Date received
- 2014-08-07
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL THE TO ADD A LARGER DIAMETER ILIAC LIMB AND ILIAC EXTENSION, A LONGERLENGTH ILIAC LIMB, AND DECREASE THE DELIVERY SYSTEM PROFILE FOR EACH ILIAC LIMB AND ILIAC EXTENSIONS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME OVATION PRIMEABDOMINAL STENT GRAFT SYSTEM WITH THE OVATION IX ILIAC STENT GRAFT AND IS INDICATED FOR THETREATMENT OF PATIENTS WITH ABDOMINAL AORTIC ANEURYSMS HAVING THE VASCULAR MORPHOLOGY SUITABLEFOR ENDOVASCULAR REPAIR, INCLUDING:1) ADEQUATEILIAC/FEMORAL ACCESS COMPATIBLE WITH VASCULAR ACCESS TECHNIQUES (FEMORALCUTDOWN OR PERCUTANEOUS), DEVICES AND/OR ACCESSORIES;2) PROXIMAL AORTIC LANDING ZONE:A) WITH AN INNER WALL DIAMETER OF NO LESS THAN 16 MM AND NO GREATER THAN 30 MM AT 13MM BELOW THE INFERIOR RENAL ARTERY, AND B) WITH AN AORTIC ANGLE OF < 60 DEGREES IF PROXIMAL NECK IS 10 ¿ MM DEGREES IF PROXIMAL NECK IS < 10 MM; AND 3) DISTAL ILIAC LANDING ZONE:A) WITH A LENGTH OF AT LEAST 10 MM, ANDB) WITH AN INNER WALL DIAMETER OF NO LESS THAN 8 MM AND NO GREATER THAN 25 MM.