PMA P900056S219

Device: ROTAPRO™ Rotational Atherectomy System
Applicant: Boston Scientific Corp
PMA number: P900056
Supplement: S219
Product code: MCX
Decision date: 2025-05-20
Classification: Cardiovascular
Generic name: CATHETER, CORONARY, ATHERECTOMY
Approval order statement: replacing an aging production mold for the ROTAPRO Advancer Piston component, supplier change of the Piston, and the transfer of inspection activities for the component from BSC to the proposed supplier

Current openFDA PMA Record#

Device: ROTAPRO™ Rotational Atherectomy System
Applicant: Boston Scientific Corp
PMA number: P900056
Supplement: S219
Product code: MCX
Generic name: CATHETER, CORONARY, ATHERECTOMY
Decision date: 2025-05-20
Decision code: OK30
Date received: 2025-04-24
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: replacing an aging production mold for the ROTAPRO Advancer Piston component, supplier change of the Piston, and the transfer of inspection activities for the component from BSC to the proposed supplier