PMA P980033S008

Device: WALLSTENT ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM
Applicant: Boston Scientific Corporation
PMA number: P980033
Supplement: S008
Product code: QKJ
Decision date: 2003-12-11
Classification: Stent, Coronary
Generic name: Stent, central venous
Approval order statement: APPROVAL FOR THE ADDITION OF TWO MANUFACTURING FACILITIES LOCATED AT BOSTON SCIENTIFIC CORP., QUINCY, MASSACHUSETTS AND BOSTON SCIENTIFIC EUROPEAN DISTRIBUTION CENTER, MAASTRICHT-AIRPORT, THE NETHERLANDS. THESE FACILITIES WILL PERFORM PACKAGING AND LABELING OPERATIONS FOR THE WALLSTENT ENDOPROSTHESIS WITH THE UNISTEP PLUS DELIVERY SYSTEM.

Current openFDA PMA Record#

Device: WALLSTENT ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM
Applicant: Boston Scientific Corporation
PMA number: P980033
Supplement: S008
Product code: QKJ
Generic name: Stent, central venous
Decision date: 2003-12-11
Decision code: APPR
Date received: 2003-11-17
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR THE ADDITION OF TWO MANUFACTURING FACILITIES LOCATED AT BOSTON SCIENTIFIC CORP., QUINCY, MASSACHUSETTS AND BOSTON SCIENTIFIC EUROPEAN DISTRIBUTION CENTER, MAASTRICHT-AIRPORT, THE NETHERLANDS. THESE FACILITIES WILL PERFORM PACKAGING AND LABELING OPERATIONS FOR THE WALLSTENT ENDOPROSTHESIS WITH THE UNISTEP PLUS DELIVERY SYSTEM.