PMA P900056S196
- Device
- Rotablator/ROTAPRO Rotational Atherectomy System
- Applicant
- Boston Scientific Corp
- PMA number
- P900056
- Supplement
- S196
- Product code
- MCX
- Decision date
- 2022-01-25
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Approval order statement
- Approval for a new adhesive.
Current openFDA PMA Record#
- Device
- Rotablator/ROTAPRO Rotational Atherectomy System
- Applicant
- Boston Scientific Corp
- PMA number
- P900056
- Supplement
- S196
- Product code
- MCX
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Decision date
- 2022-01-25
- Decision code
- APPR
- Date received
- 2021-11-08
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a new adhesive.