PMA P900056S165
- Device
- Rotablator Rotational Atherectomy System
- Applicant
- Boston Scientific Corp
- PMA number
- P900056
- Supplement
- S165
- Product code
- MCX
- Decision date
- 2017-11-02
- Classification
- Catheter, Coronary, Atherectomy
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Approval order statement
- Approval for a change in the UV Bond Adhesive used in the RotaLink Advancer.
Current openFDA PMA Record#
- Device
- Rotablator Rotational Atherectomy System
- Applicant
- Boston Scientific Corp
- PMA number
- P900056
- Supplement
- S165
- Product code
- MCX
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Decision date
- 2017-11-02
- Decision code
- APPR
- Date received
- 2017-08-07
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a change in the UV Bond Adhesive used in the RotaLink Advancer.