POWERLINK STENT GRAFT WITH INTUITRAK DELIVERY SYSTEM
FDA premarket approval P040002/S028 · decided 2010-05-13
Approval details
- PMA number
- P040002
- Supplement
- S028
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- POWERLINK STENT GRAFT WITH INTUITRAK DELIVERY SYSTEM
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Endologix, LLC
- Date received
- 2010-04-08
- Decision date
- 2010-05-13
- Days to decision
- 35 days
- Decision code
- OK30
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- CHANGE TO THE HEMOSTASIS HANDLE ASSEMBLY OF THE DEVICE.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.