PMA P900056S214
- Device
- Rotablator™and ROTAPRO™ Rotational Atherectomy System
- Applicant
- Boston Scientific Corp
- PMA number
- P900056
- Supplement
- S214
- Product code
- MCX
- Decision date
- 2023-12-06
- Classification
- Cardiovascular
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Approval order statement
- remove the destructive pull testing step during manufacturing of the RotaWire and ROTAWIRE Drive guidewires
Current openFDA PMA Record#
- Device
- Rotablator™and ROTAPRO™ Rotational Atherectomy System
- Applicant
- Boston Scientific Corp
- PMA number
- P900056
- Supplement
- S214
- Product code
- MCX
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Decision date
- 2023-12-06
- Decision code
- OK30
- Date received
- 2023-11-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- remove the destructive pull testing step during manufacturing of the RotaWire and ROTAWIRE Drive guidewires