PMA P020018S019
- Device
- ZENITH AAA ENDOCASCULAR GRAFT WITH H + L-B ONE-SHOT INTRODUCTION SYSTEM
- Applicant
- Cook, Inc.
- PMA number
- P020018
- Supplement
- S019
- Product code
- MIH
- Decision date
- 2006-12-06
- Classification
- System, Endovascular Graft, Aortic Aneurysm Treatment
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- USE OF A CONTRACT MANUFACTURER FOR THE MAIN BODY GRAFT SUBASSEMBLY.
Current openFDA PMA Record#
- Device
- ZENITH AAA ENDOCASCULAR GRAFT WITH H + L-B ONE-SHOT INTRODUCTION SYSTEM
- Applicant
- Cook, Inc.
- PMA number
- P020018
- Supplement
- S019
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2006-12-06
- Decision code
- OK30
- Date received
- 2006-11-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- USE OF A CONTRACT MANUFACTURER FOR THE MAIN BODY GRAFT SUBASSEMBLY.