PMA P020018S011

Device: ZENITH AAA ENDOVASCULAR GRAFT WITH H&L-B ONE SHOT INTRODUCTION SYSTEM
Applicant: Cook, Inc.
PMA number: P020018
Supplement: S011
Product code: MIH
Decision date: 2008-07-01
Classification: System, Endovascular Graft, Aortic Aneurysm Treatment
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement: APPROVAL OR THE: 1) ADDITION OF AN AUTOMATED LASER WELDING PROCESS; AND 2) REMOVAL OF THE SUBSEQUENT ULTRASONIC CLEANING STEP FROM THE SOLDERING PROCESS.

Current openFDA PMA Record#

Device: ZENITH AAA ENDOVASCULAR GRAFT WITH H&L-B ONE SHOT INTRODUCTION SYSTEM
Applicant: Cook, Inc.
PMA number: P020018
Supplement: S011
Product code: MIH
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date: 2008-07-01
Decision code: APPR
Date received: 2006-09-18
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL OR THE: 1) ADDITION OF AN AUTOMATED LASER WELDING PROCESS; AND 2) REMOVAL OF THE SUBSEQUENT ULTRASONIC CLEANING STEP FROM THE SOLDERING PROCESS.