PMA P040002S003
- Device
- POWERLINK SYSTEM
- Applicant
- Endologix, LLC
- PMA number
- P040002
- Supplement
- S003
- Product code
- MIH
- Decision date
- 2006-02-01
- Classification
- System, Endovascular Graft, Aortic Aneurysm Treatment
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- SWITCH FROM TWO-PART EPOXY REQUIRING 48-HOUR CURE TIME TO TWO-PART EPOXY REQUIRING 1-HOUR CURE TIME.
Current openFDA PMA Record#
- Device
- POWERLINK SYSTEM
- Applicant
- Endologix, LLC
- PMA number
- P040002
- Supplement
- S003
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2006-02-01
- Decision code
- OK30
- Date received
- 2006-01-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- SWITCH FROM TWO-PART EPOXY REQUIRING 48-HOUR CURE TIME TO TWO-PART EPOXY REQUIRING 1-HOUR CURE TIME.