PMA P990017

Device: ANCURE SYSTEM
Applicant: Boston Scientific Corp
PMA number: P990017
Supplement: S013
Product code: MIH
Decision date: 2003-08-08
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement: APPROVAL FOR THE FORMAT TO BE USED FOR THE CLINICAL UPDATE THAT WILL BE PROVIDED TO PHYSICIANS USERS AT LEAST ANNUALLY. THE INFORMATION CONTAINED IN THIS UPDATE WILL BE PROVIDED TO THE FDA VIA THE PMA ANNUAL REPORT.

Current openFDA PMA Record

Device: ANCURE SYSTEM
Applicant: Boston Scientific Corp
PMA number: P990017
Supplement: S038
Product code: MIH
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date: 2003-08-08
Decision code: APPR
Date received: 2003-02-10
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol
Approval order statement: APPROVAL FOR THE FORMAT TO BE USED FOR THE CLINICAL UPDATE THAT WILL BE PROVIDED TO PHYSICIANS USERS AT LEAST ANNUALLY. THE INFORMATION CONTAINED IN THIS UPDATE WILL BE PROVIDED TO THE FDA VIA THE PMA ANNUAL REPORT.