PMA P980033S006

Device: WALLSTENT VENOUS ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM
Applicant: Boston Scientific Corporation
PMA number: P980033
Supplement: S006
Product code: QKJ
Decision date: 2003-04-01
Classification: Stent, Coronary
Generic name: Stent, central venous
Approval order statement: APPROVAL FOR CHANGES TO THE INSTRUCTIONS FOR USE (IFU) MANUAL, NAMELY A MODIFICATION TO THE SIZING REQUIREMENTS OF THE INTRODUCER SHEATHS AND A MODIFICATION TO THE DESCRIPTION OF THE RECOMMENDED GUIDE WIRE TO BE USED WITH THE WALLSTENT VENOUS ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM.

Current openFDA PMA Record#

Device: WALLSTENT VENOUS ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM
Applicant: Boston Scientific Corporation
PMA number: P980033
Supplement: S006
Product code: QKJ
Generic name: Stent, central venous
Decision date: 2003-04-01
Decision code: APPR
Date received: 2003-03-12
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR CHANGES TO THE INSTRUCTIONS FOR USE (IFU) MANUAL, NAMELY A MODIFICATION TO THE SIZING REQUIREMENTS OF THE INTRODUCER SHEATHS AND A MODIFICATION TO THE DESCRIPTION OF THE RECOMMENDED GUIDE WIRE TO BE USED WITH THE WALLSTENT VENOUS ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM.