ENDOLOGIX POWERLINK SYSTEM
FDA premarket approval P040002/S001 · decided 2005-02-15
Approval details
- PMA number
- P040002
- Supplement
- S001
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- ENDOLOGIX POWERLINK SYSTEM
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Endologix, LLC
- Date received
- 2004-12-03
- Decision date
- 2005-02-15
- Days to decision
- 74 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR THE POST-APPROVAL STUDY PROTOCOL.
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