POWERLINK SYSTEM ANEURYSM STENT GRAFT
FDA premarket approval P040002/S013 · decided 2008-02-21
Approval details
- PMA number
- P040002
- Supplement
- S013
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- POWERLINK SYSTEM ANEURYSM STENT GRAFT
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Endologix, LLC
- Date received
- 2007-12-26
- Decision date
- 2008-02-21
- Days to decision
- 57 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR AN ALTERNATE STERILIZATION SITE LOCATED AT STERIGENICS US, INC., LOS ANGELES, CALIFORNIA.
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