PMA P020018S014
- Device
- ZENITH AAA ENDOVASCULAR GRAFT WITH H&L-B ONE SHOT INTRODUCTION SYSTEM
- Applicant
- Cook, Inc.
- PMA number
- P020018
- Supplement
- S014
- Product code
- MIH
- Decision date
- 2006-10-17
- Classification
- System, Endovascular Graft, Aortic Aneurysm Treatment
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- ALLOWING THE INTERNAL AND EXTERNAL THREADS OF THE DILATOR TIP (A COMPONENT OF THE H&L-B ONE-SHOT INTRODUCTION SYSTEM) TO BE MACHINED BY AN OUTSIDE VENDOR.
Current openFDA PMA Record#
- Device
- ZENITH AAA ENDOVASCULAR GRAFT WITH H&L-B ONE SHOT INTRODUCTION SYSTEM
- Applicant
- Cook, Inc.
- PMA number
- P020018
- Supplement
- S014
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2006-10-17
- Decision code
- OK30
- Date received
- 2006-09-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ALLOWING THE INTERNAL AND EXTERNAL THREADS OF THE DILATOR TIP (A COMPONENT OF THE H&L-B ONE-SHOT INTRODUCTION SYSTEM) TO BE MACHINED BY AN OUTSIDE VENDOR.