PMA P900056S195

Device: Rotablator Rotational Angioplasty System, ROTAPRO Rotational Atherectomy System
Applicant: Boston Scientific Corp
PMA number: P900056
Supplement: S195
Product code: MCX
Decision date: 2021-11-26
Generic name: CATHETER, CORONARY, ATHERECTOMY
Approval order statement: Rotablator Rotational Angioplasty System, ROTAPRO Rotational Atherectomy System and the Alair Bronchial Thermoplasty System is approved for the addition of automated ultrasonic cleaning equipment with forced air dryer at the supplier for components used in the Rotalink and ROTAPRO Advancers and Alair Catheter.

Current openFDA PMA Record#

Device: Rotablator Rotational Angioplasty System, ROTAPRO Rotational Atherectomy System
Applicant: Boston Scientific Corp
PMA number: P900056
Supplement: S195
Product code: MCX
Generic name: CATHETER, CORONARY, ATHERECTOMY
Decision date: 2021-11-26
Decision code: OK30
Date received: 2021-10-28
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Rotablator Rotational Angioplasty System, ROTAPRO Rotational Atherectomy System and the Alair Bronchial Thermoplasty System is approved for the addition of automated ultrasonic cleaning equipment with forced air dryer at the supplier for components used in the Rotalink and ROTAPRO Advancers and Alair Catheter.