PMA P900056S226
- Device
- ROTAPRO™ Rotational Atherectomy Systems
- Applicant
- Boston Scientific Corp
- PMA number
- P900056
- Supplement
- S226
- Product code
- MCX
- Decision date
- 2026-10-21
- Classification
- Cardiovascular
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Approval order statement
- a design change to a component of the Pneumatic Kit for the ROTAPRO console
Current openFDA PMA Record#
- Device
- ROTAPRO™ Rotational Atherectomy Systems
- Applicant
- Boston Scientific Corp
- PMA number
- P900056
- Supplement
- S226
- Product code
- MCX
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Decision date
- 2026-10-21
- Decision code
- APPR
- Date received
- 2026-07-23
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- a design change to a component of the Pneumatic Kit for the ROTAPRO console