PMA P040002S015
- Device
- POWERLINK SYSTEM
- Applicant
- Endologix, LLC
- PMA number
- P040002
- Supplement
- S015
- Product code
- MIH
- Decision date
- 2008-03-21
- Classification
- System, Endovascular Graft, Aortic Aneurysm Treatment
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- APPROVAL FOR TWO NEW LIMB EXTENSION ACCESSORIES, THE TAPERED LIMB EXTENSION AND THE STEPPED LIMB EXTENSION.
Current openFDA PMA Record#
- Device
- POWERLINK SYSTEM
- Applicant
- Endologix, LLC
- PMA number
- P040002
- Supplement
- S015
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2008-03-21
- Decision code
- APPR
- Date received
- 2008-02-29
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR TWO NEW LIMB EXTENSION ACCESSORIES, THE TAPERED LIMB EXTENSION AND THE STEPPED LIMB EXTENSION.