ENDOLOGIX POWERLINK SYSTEM
FDA premarket approval P040002 · decided 2004-10-29
Approval details
- PMA number
- P040002
- Trade name
- ENDOLOGIX POWERLINK SYSTEM
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Endologix, LLC
- Date received
- 2004-01-08
- Decision date
- 2004-10-29
- Days to decision
- 295 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR THE ENDOLOGIX POWERLINK SYSTEM. THE POWERLINK SYSTEM BIFURCATED MODELS AND PROXIMAL CUFF AND LIMB EXTENSION ACCESSORIES ARE INDICATED FOR ENDOVASCULAR TREATMENT IN PATIENTS WITH AAA. THE ENDOLOGIX POWERLINK SYSTEM IS INDICATED FOR PATIENTS WITH SUITABLE ANEURYSM MORPHOLOGY FOR ENDOVASCULAR REPAIR, INCLUDING: 1) ADEQUATE ILIAC/FEMORAL ACCESS COMPATIBLE WITH THE REQUIRED DELIVERY SYSTEMS (A DIAMETER OF >= 7 MM). 2) NON-ANEURYSMAL AORTIC NECK BETWEEN THE RENAL ARTERIES AND THE ANEURYSM
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