PMA P040002S027
- Device
- POWERLINK SYSTEMWITH INTUITRAK DELIVERY SYSTEM
- Applicant
- Endologix, LLC
- PMA number
- P040002
- Supplement
- S027
- Product code
- MIH
- Decision date
- 2010-05-12
- Classification
- System, Endovascular Graft, Aortic Aneurysm Treatment
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- APPROVAL FOR NEW POWERLINK SYSTEM MODELS, INCLUDING BIFURCATED DEVICES WITH NEW LENGTHS AND DIAMETERS, LIMB EXTENSIONS WITH NEW LENGTHS, AND AORTIC EXTENSIONS WITH NEW LENGTHS.
Current openFDA PMA Record#
- Device
- POWERLINK SYSTEMWITH INTUITRAK DELIVERY SYSTEM
- Applicant
- Endologix, LLC
- PMA number
- P040002
- Supplement
- S027
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2010-05-12
- Decision code
- APPR
- Date received
- 2010-03-25
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR NEW POWERLINK SYSTEM MODELS, INCLUDING BIFURCATED DEVICES WITH NEW LENGTHS AND DIAMETERS, LIMB EXTENSIONS WITH NEW LENGTHS, AND AORTIC EXTENSIONS WITH NEW LENGTHS.