PMA P020018S003
- Device
- ZENITH FLEX AAA ENDOVASCULAR GRAFT AND H&L-B ONE-SHOT INTRODUCTION SYSTEM
- Applicant
- Cook, Inc.
- PMA number
- P020018
- Supplement
- S003
- Product code
- MIH
- Decision date
- 2004-04-15
- Classification
- System, Endovascular Graft, Aortic Aneurysm Treatment
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- APPROVAL TO INCREASE THE STENT SPACING (FROM 0-3 MM TO 5 += 1MM) ON THE MAIN BODY AND THE MAIN BODY EXTENSION COMPONENTS OF THE ZENITH AAA ENDOVASCULAR GRAFT.
Current openFDA PMA Record#
- Device
- ZENITH FLEX AAA ENDOVASCULAR GRAFT AND H&L-B ONE-SHOT INTRODUCTION SYSTEM
- Applicant
- Cook, Inc.
- PMA number
- P020018
- Supplement
- S003
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2004-04-15
- Decision code
- APPR
- Date received
- 2003-12-22
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL TO INCREASE THE STENT SPACING (FROM 0-3 MM TO 5 += 1MM) ON THE MAIN BODY AND THE MAIN BODY EXTENSION COMPONENTS OF THE ZENITH AAA ENDOVASCULAR GRAFT.