PMA P990017S010

Device: ANCURE TUBE AND BIFURCATED ENDOGRAFT SYSTEM
Applicant: Boston Scientific Corp
PMA number: P990017
Supplement: S010
Product code: MIH
Decision date: 2000-11-21
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement: APPROVAL FOR THE ADDITION OF A COATING TO THE INFERIOR (TUBE ONLY) AND SUPERIOR CAPSULES (ALL CONFIGURATIONS) OF THE ANCURE(R) DELIVERY CATHETERS.

Current openFDA PMA Record

Device: ANCURE TUBE AND BIFURCATED ENDOGRAFT SYSTEM
Applicant: Boston Scientific Corp
PMA number: P990017
Supplement: S010
Product code: MIH
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date: 2000-11-21
Decision code: APPR
Date received: 2000-09-25
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE ADDITION OF A COATING TO THE INFERIOR (TUBE ONLY) AND SUPERIOR CAPSULES (ALL CONFIGURATIONS) OF THE ANCURE(R) DELIVERY CATHETERS.