PMA P900056S048
- Device
- ROTABLATOR(R) ROTALINK
- Applicant
- Boston Scientific Corp
- PMA number
- P900056
- Supplement
- S048
- Product code
- MCX
- Decision date
- 2000-07-21
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Approval order statement
- APPROVAL FOR THE USE OF A MODIFIED FORMED CATHETER TUBE IN THE RATABLATOR(R) ROTALINK SYSTEM.
Current openFDA PMA Record#
- Device
- ROTABLATOR(R) ROTALINK
- Applicant
- Boston Scientific Corp
- PMA number
- P900056
- Supplement
- S048
- Product code
- MCX
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Decision date
- 2000-07-21
- Decision code
- APPR
- Date received
- 2000-06-19
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE USE OF A MODIFIED FORMED CATHETER TUBE IN THE RATABLATOR(R) ROTALINK SYSTEM.