- Device
- Rotablator Rotational Atherectomy System, ROTAPRO Rotational Atherectomy System
- Applicant
- Boston Scientific Corp
- PMA number
- P900056
- Supplement
- S185
- Product code
- MCX
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Decision date
- 2020-06-16
- Decision code
- OK30
- Date received
- 2020-05-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modifications to associated acceptance activities/inspections for the supplied infusion hose assembly for Rotalink and Rotapro advancers.