POWERLINK SYSTEM WITH VISIFLEX SUREPASS DELIVERY CATHETER SYSTEM
FDA premarket approval P040002/S009 · decided 2007-03-29
Approval details
- PMA number
- P040002
- Supplement
- S009
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- POWERLINK SYSTEM WITH VISIFLEX SUREPASS DELIVERY CATHETER SYSTEM
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Endologix, LLC
- Date received
- 2007-02-28
- Decision date
- 2007-03-29
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- CHANGE TO THE SUREPASS CONTRALATERAL LIMB SHEATH/GUIDEWIRE ASSEMBLY OF THE VISIFLEX DELIVERY SYSTEM.
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