POWERLINK SYSTEM FOR AAA
FDA premarket approval P040002/S026 · decided 2010-07-28
Approval details
- PMA number
- P040002
- Supplement
- S026
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- POWERLINK SYSTEM FOR AAA
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Endologix, LLC
- Date received
- 2010-02-05
- Decision date
- 2010-07-28
- Days to decision
- 173 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR A MODIFICATION TO THE SUPRARENAL PROXIMAL EXTENSION ACCESSORY AND FOR ADDITIONAL LENGTHS OF SUPRARENAL AND INFRARENAL PROXIMAL EXTENSION ACCESSORIES.
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