- Device
- Rotablator Rotational Atherectomy System (Rotablator, RotaLink Plus, Rotalink Burr), ROTAPRO Rotational Atherectomy Syst
- Applicant
- Boston Scientific Corp
- PMA number
- P900056
- Supplement
- S192
- Product code
- MCX
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Decision date
- 2021-06-24
- Decision code
- OK30
- Date received
- 2021-05-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modifications to quality control inspection equipment for a supplied component.