ENDOLOGIX POWERLINK SYSTEM
FDA premarket approval P040002/S062 · decided 2019-10-08
Approval details
- PMA number
- P040002
- Supplement
- S062
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ENDOLOGIX POWERLINK SYSTEM
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Endologix, LLC
- Date received
- 2019-06-28
- Decision date
- 2019-10-08
- Days to decision
- 102 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Approval for a shelf-life extension for the AFX2 device system.
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