PMA P880065

Device: AORTIC VALVULOPLASTY BALLOON DILATATION CATHETER
Applicant: Boston Scientific Corp
PMA number: P880065
Supplement: S004
Product code: LOT
Decision date: 2004-01-07
Generic name: PULSE-GENERATOR, PROGRAM MODULE
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: AORTIC VALVULOPLASTY BALLOON DILATATION CATHETER
Applicant: Boston Scientific Corp
PMA number: P880065
Supplement: S009
Product code: LOT
Generic name: PULSE-GENERATOR, PROGRAM MODULE
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.