POWERLINK SYSTEM WITH INTUI TRAK DELIVERY SYSTEM
FDA premarket approval P040002/S025 · decided 2009-09-16
Approval details
- PMA number
- P040002
- Supplement
- S025
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- POWERLINK SYSTEM WITH INTUI TRAK DELIVERY SYSTEM
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Endologix, LLC
- Date received
- 2009-09-01
- Decision date
- 2009-09-16
- Days to decision
- 15 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR CHANGES MADE TO THE LABELING TO INCLUDE INSTRUCTIONS FOR THE OPTION OF DEPLOYING OF THE IPSILATERAL LEG FIRST.
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