PMA P900056S193
- Device
- ROTAPRO Rotational Atherectomy System
- Applicant
- Boston Scientific Corp
- PMA number
- P900056
- Supplement
- S193
- Product code
- MCX
- Decision date
- 2021-07-06
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Approval order statement
- Tightening of device component specifications.
Current openFDA PMA Record#
- Device
- ROTAPRO Rotational Atherectomy System
- Applicant
- Boston Scientific Corp
- PMA number
- P900056
- Supplement
- S193
- Product code
- MCX
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Decision date
- 2021-07-06
- Decision code
- OK30
- Date received
- 2021-06-07
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Tightening of device component specifications.