PMA P900056S228
- Device
- ROTAPRO™ Rotational Atherectomy System
- Applicant
- Boston Scientific Corp
- PMA number
- P900056
- Supplement
- S228
- Product code
- MCX
- Decision date
- 2026-10-20
- Classification
- Cardiovascular
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Approval order statement
- updates to the PCBA adhesive inspection process and introduction of new adhesive dispensers for the ROTAPRO™ Rotational Atherectomy System
Current openFDA PMA Record#
- Device
- ROTAPRO™ Rotational Atherectomy System
- Applicant
- Boston Scientific Corp
- PMA number
- P900056
- Supplement
- S228
- Product code
- MCX
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Decision date
- 2026-10-20
- Decision code
- OK30
- Date received
- 2026-09-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- updates to the PCBA adhesive inspection process and introduction of new adhesive dispensers for the ROTAPRO™ Rotational Atherectomy System