PMA P020018S056
- Device
- ZENITH AAA ENDOVASCULAR GRAFT AND H&L-B ONE-SHOT INTRODUCTINO SYSTEM
- Applicant
- Cook, Inc.
- PMA number
- P020018
- Supplement
- S056
- Product code
- MIH
- Decision date
- 2016-06-03
- Classification
- System, Endovascular Graft, Aortic Aneurysm Treatment
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- Approval to change the in-process sampling for endotoxin testing.
Current openFDA PMA Record#
- Device
- ZENITH AAA ENDOVASCULAR GRAFT AND H&L-B ONE-SHOT INTRODUCTINO SYSTEM
- Applicant
- Cook, Inc.
- PMA number
- P020018
- Supplement
- S056
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2016-06-03
- Decision code
- APPR
- Date received
- 2016-05-04
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval to change the in-process sampling for endotoxin testing.