PMA P900056S183

Device: Rotablator or ROTAPRO Rotational Atherectomy System
Applicant: Boston Scientific Corp
Product code: MCX
Decision date: 2021-02-05
Generic name: CATHETER, CORONARY, ATHERECTOMY
Approval order statement: Approval for a change in the core wire supplier to increase torqueability of the Rotawire guidewires (Floppy and Extra Support), and the associated rebranding of the Rotawire guidewires as the Rotawire Drive guidewires (Floppy and Extra Support).

Current openFDA PMA Record#

Device: Rotablator or ROTAPRO Rotational Atherectomy System
Applicant: Boston Scientific Corp
PMA number: P900056
Supplement: S183
Product code: MCX
Generic name: CATHETER, CORONARY, ATHERECTOMY
Decision date: 2021-02-05
Decision code: APPR
Date received: 2020-03-10
Supplement type: Normal 180 Day Track
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for a change in the core wire supplier to increase torqueability of the Rotawire guidewires (Floppy and Extra Support), and the associated rebranding of the Rotawire guidewires as the Rotawire Drive guidewires (Floppy and Extra Support).