PMA P020018S018
- Device
- ZENITH AAA ENDOVASCULAR GRAFT WITH H&L-B ONE SHOT INTRODUCTION SYSTEM
- Applicant
- Cook, Inc.
- PMA number
- P020018
- Supplement
- S018
- Product code
- MIH
- Decision date
- 2006-10-25
- Classification
- System, Endovascular Graft, Aortic Aneurysm Treatment
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- ALTERNATIVE METHOD TO TEMPORARILY ATTACH SELECTED EXTERNAL Z-STENTS TO THE GRAFT MATERIAL PRIOR TO PERMANENT SEWING.
Current openFDA PMA Record#
- Device
- ZENITH AAA ENDOVASCULAR GRAFT WITH H&L-B ONE SHOT INTRODUCTION SYSTEM
- Applicant
- Cook, Inc.
- PMA number
- P020018
- Supplement
- S018
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2006-10-25
- Decision code
- OK30
- Date received
- 2006-10-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ALTERNATIVE METHOD TO TEMPORARILY ATTACH SELECTED EXTERNAL Z-STENTS TO THE GRAFT MATERIAL PRIOR TO PERMANENT SEWING.