PMA P990017S006

Device: ANCURE ENDOGRAFT SYSTEM/ILIAC BALLOON CATHETER
Applicant: Boston Scientific Corp
PMA number: P990017
Supplement: S006
Product code: MIH
Decision date: 2000-04-14
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement: Approval for the addition of a hydrophilic coating with the trade name HYDRACOAT to the outer surface of the ANCURE Delivery Catheter jacket.

Current openFDA PMA Record

Device: ANCURE ENDOGRAFT SYSTEM/ILIAC BALLOON CATHETER
Applicant: Boston Scientific Corp
PMA number: P990017
Supplement: S006
Product code: MIH
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date: 2000-04-14
Decision code: APPR
Date received: 2000-03-15
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for the addition of a hydrophilic coating with the trade name HYDRACOAT to the outer surface of the ANCURE Delivery Catheter jacket.