POWERLINK SYSTEM WITH INTUITRAK DELIVERY SYSTEM
FDA premarket approval P040002/S039 · decided 2013-04-16
Approval details
- PMA number
- P040002
- Supplement
- S039
- Supplement type
- Normal 180 Day Track
- Trade name
- POWERLINK SYSTEM WITH INTUITRAK DELIVERY SYSTEM
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Endologix, LLC
- Date received
- 2012-07-05
- Decision date
- 2013-04-16
- Days to decision
- 285 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR THE ADDITION OF BILATERAL PERCUTANEOUS ACCESS TO THE DEVICE LABELING.
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