POWERLINK SYSTEM
FDA premarket approval P040002/S015 · decided 2008-03-21
Approval details
- PMA number
- P040002
- Supplement
- S015
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- POWERLINK SYSTEM
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Endologix, LLC
- Date received
- 2008-02-29
- Decision date
- 2008-03-21
- Days to decision
- 21 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR TWO NEW LIMB EXTENSION ACCESSORIES, THE TAPERED LIMB EXTENSION AND THE STEPPED LIMB EXTENSION.
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