PMA P980033S005

Device: WALLSTENT (TIPS,ILAC,VENOUS)ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM
Applicant: Boston Scientific Corporation
PMA number: P980033
Supplement: S005
Product code: QKJ
Decision date: 2003-01-17
Classification: Stent, Coronary
Generic name: Stent, central venous
Approval order statement: CHANGE IN THE MANUFACTURING PROCESS OF THE WALLSTENT DELIVERY SYSTEM WHICH INVOLVES THE REPLACEMENT OF THE CATHETER HUB BOND TO STAINLESS STEEL TUBE BOND CURE TIME WITH A REDUCED SET TIME.

Current openFDA PMA Record#

Device: WALLSTENT (TIPS,ILAC,VENOUS)ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM
Applicant: Boston Scientific Corporation
PMA number: P980033
Supplement: S005
Product code: QKJ
Generic name: Stent, central venous
Decision date: 2003-01-17
Decision code: OK30
Date received: 2002-12-18
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGE IN THE MANUFACTURING PROCESS OF THE WALLSTENT DELIVERY SYSTEM WHICH INVOLVES THE REPLACEMENT OF THE CATHETER HUB BOND TO STAINLESS STEEL TUBE BOND CURE TIME WITH A REDUCED SET TIME.