PMA P900056S217
- Device
- Rotablator and ROTAPRO Rotational Atherectomy System
- Applicant
- Boston Scientific Corp
- PMA number
- P900056
- Supplement
- S217
- Product code
- MCX
- Decision date
- 2024-06-05
- Classification
- Cardiovascular
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Approval order statement
- approval to change the pouch supplier and update pouch material and dimensions for the ROTAWIRE Drive Guidewire and wireClip Torquer.
Current openFDA PMA Record#
- Device
- Rotablator and ROTAPRO Rotational Atherectomy System
- Applicant
- Boston Scientific Corp
- PMA number
- P900056
- Supplement
- S217
- Product code
- MCX
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Decision date
- 2024-06-05
- Decision code
- APPR
- Date received
- 2024-03-08
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- approval to change the pouch supplier and update pouch material and dimensions for the ROTAWIRE Drive Guidewire and wireClip Torquer.