PMA P900056S204
- Device
- Rotablator and ROTAPRO Rotational Atherectomy System
- Applicant
- Boston Scientific Corp
- PMA number
- P900056
- Supplement
- S204
- Product code
- MCX
- Decision date
- 2023-02-02
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Approval order statement
- Additional supplier for a switch component.
Current openFDA PMA Record#
- Device
- Rotablator and ROTAPRO Rotational Atherectomy System
- Applicant
- Boston Scientific Corp
- PMA number
- P900056
- Supplement
- S204
- Product code
- MCX
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Decision date
- 2023-02-02
- Decision code
- OK30
- Date received
- 2023-01-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Additional supplier for a switch component.