POWERLINK SYSTEM
FDA premarket approval P040002/S023 · decided 2009-02-20
Approval details
- PMA number
- P040002
- Supplement
- S023
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- POWERLINK SYSTEM
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Endologix, LLC
- Date received
- 2009-01-22
- Decision date
- 2009-02-20
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL TO MOVE THE 34MM ACCESSORIES OVER TO INTUITRAK DELIVERY SYSTEM LINE AS WELL AS MAKING A STAND ALONE VERSION OF THE 34MM BIFURCATED BODY DELIVERY SHEATH AVAILABLE.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.