PMA P020018S008

Device: COOK ZENITH RENU AAA ANCILLARY GRAFT
Applicant: Cook, Inc.
PMA number: P020018
Supplement: S008
Product code: MIH
Decision date: 2006-02-09
Classification: System, Endovascular Graft, Aortic Aneurysm Treatment
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement: APPROVAL FOR MODIFYING THE INSTRUCTIONS FOR USE (IFU) FOR THE COOK ZENITH. RENU AAA ANCILLARY GRAFT TO REINFORCE THE PRECAUTION NOT TO INFLATE THE MOLDING BALLOON IN THE VESSEL OUTSIDE THE GRAFT.

Current openFDA PMA Record#

Device: COOK ZENITH RENU AAA ANCILLARY GRAFT
Applicant: Cook, Inc.
PMA number: P020018
Supplement: S008
Product code: MIH
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date: 2006-02-09
Decision code: APPR
Date received: 2006-01-09
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR MODIFYING THE INSTRUCTIONS FOR USE (IFU) FOR THE COOK ZENITH. RENU AAA ANCILLARY GRAFT TO REINFORCE THE PRECAUTION NOT TO INFLATE THE MOLDING BALLOON IN THE VESSEL OUTSIDE THE GRAFT.