PMA P980033S011

Device: WALLSTENT (TIPS AND VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM
Applicant: Boston Scientific Corporation
PMA number: P980033
Supplement: S011
Product code: QKJ
Decision date: 2004-07-22
Classification: Stent, Coronary
Generic name: Stent, central venous
Approval order statement: REDUCTION IN BOND CURE TIMES FOR TWO PROCESSING STEPS USED IN THE MANUFACTURE OF THE STENT DELIVERY CATHETER FOR THE ABOVE-STATED DEVICES.

Current openFDA PMA Record#

Device: WALLSTENT (TIPS AND VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM
Applicant: Boston Scientific Corporation
PMA number: P980033
Supplement: S011
Product code: QKJ
Generic name: Stent, central venous
Decision date: 2004-07-22
Decision code: OK30
Date received: 2004-06-25
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: REDUCTION IN BOND CURE TIMES FOR TWO PROCESSING STEPS USED IN THE MANUFACTURE OF THE STENT DELIVERY CATHETER FOR THE ABOVE-STATED DEVICES.