Endologix Powerlink System
FDA premarket approval P040002/S058 · decided 2017-06-02
Approval details
- PMA number
- P040002
- Supplement
- S058
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Endologix Powerlink System
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Endologix, LLC
- Date received
- 2017-02-07
- Decision date
- 2017-06-02
- Days to decision
- 115 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Approval for the removal of an on-going sampling plan for the AFX2 Endovascular AAA System.
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