PMA P900056S080

Device: ROTOBLATOR ROTATIONAL ANGIOPLASTY SYSTEM WIRE
Applicant: Boston Scientific Corp
PMA number: P900056
Supplement: S080
Product code: MCX
Decision date: 2004-01-07
Classification: Catheter, Coronary, Atherectomy
Generic name: CATHETER, CORONARY, ATHERECTOMY
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: ROTOBLATOR ROTATIONAL ANGIOPLASTY SYSTEM WIRE
Applicant: Boston Scientific Corp
PMA number: P900056
Supplement: S080
Product code: MCX
Generic name: CATHETER, CORONARY, ATHERECTOMY
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.