PMA P980033S002

Device: WALLSTENT (TIPS, ILIAC, VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEMS
Applicant: Boston Scientific Corporation
PMA number: P980033
Supplement: S002
Product code: QKJ
Decision date: 2002-05-10
Classification: Stent, Coronary
Generic name: Stent, central venous
Approval order statement: APPROVAL FOR AN ALTERNATE MANUFACTURING FACILITY FOR THE STENT COMPONENT OF THE WALLSTENT. PRODUCTS LOCATED AT BOSTON SCIENTIFIC IRELAND LTD. (BSIL), GALWAY, IRELAND.

Current openFDA PMA Record#

Device: WALLSTENT (TIPS, ILIAC, VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEMS
Applicant: Boston Scientific Corporation
PMA number: P980033
Supplement: S002
Product code: QKJ
Generic name: Stent, central venous
Decision date: 2002-05-10
Decision code: APPR
Date received: 2002-04-24
Supplement type: Normal 180 Day Track
Supplement reason: Express GMP Supplement
Approval order statement: APPROVAL FOR AN ALTERNATE MANUFACTURING FACILITY FOR THE STENT COMPONENT OF THE WALLSTENT. PRODUCTS LOCATED AT BOSTON SCIENTIFIC IRELAND LTD. (BSIL), GALWAY, IRELAND.