PMA P900056S194
- Device
- Rotablator™and ROTAPRO™ Rotational Atherectomy System, RotaWire™ Guidewire and wireClip™ Torquer, ROTAWIRE™ Drive Guidew
- Applicant
- Boston Scientific Corp
- PMA number
- P900056
- Supplement
- S194
- Product code
- MCX
- Decision date
- 2021-10-05
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Approval order statement
- Addition of a new plasma welding machine.
Current openFDA PMA Record#
- Device
- Rotablator™and ROTAPRO™ Rotational Atherectomy System, RotaWire™ Guidewire and wireClip™ Torquer, ROTAWIRE™ Drive Guidew
- Applicant
- Boston Scientific Corp
- PMA number
- P900056
- Supplement
- S194
- Product code
- MCX
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Decision date
- 2021-10-05
- Decision code
- OK30
- Date received
- 2021-09-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of a new plasma welding machine.