PMA P980033S009

Device: WALLSTENT VENOUS ENDOPROSTHESIS
Applicant: Boston Scientific Corporation
PMA number: P980033
Supplement: S009
Product code: QKJ
Decision date: 2004-01-07
Classification: Stent, Coronary
Generic name: Stent, central venous
Approval order statement: CHANGE IN THE MANUFACTURING PROCESS WHICH INVOLVED THE USE OF AN ALTERNATE BIOLOGICAL INDICATOR (BI) WITH A SHORTER LABELED INCUBATION TIME OF FOUR (4) HOURS FOR USE IN MONITORING THE EO STERILIZATION CYCLES AND STERILIZATION PROCESS VALIDATION.

Current openFDA PMA Record#

Device: WALLSTENT VENOUS ENDOPROSTHESIS
Applicant: Boston Scientific Corporation
PMA number: P980033
Supplement: S009
Product code: QKJ
Generic name: Stent, central venous
Decision date: 2004-01-07
Decision code: OK30
Date received: 2003-12-08
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGE IN THE MANUFACTURING PROCESS WHICH INVOLVED THE USE OF AN ALTERNATE BIOLOGICAL INDICATOR (BI) WITH A SHORTER LABELED INCUBATION TIME OF FOUR (4) HOURS FOR USE IN MONITORING THE EO STERILIZATION CYCLES AND STERILIZATION PROCESS VALIDATION.