PMA P900056S129
- Device
- ROTAWIRE GUIDEWIRE WITH WIRECLIP TORQUER
- Applicant
- Boston Scientific Corp
- PMA number
- P900056
- Supplement
- S129
- Product code
- MCX
- Decision date
- 2013-12-15
- Classification
- Catheter, Coronary, Atherectomy
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Approval order statement
- REMOVAL OF 34 OF THE 48 QUALITY INSPECTIONS WITHIN THE ROTAWIRE GUIDEWIRE MANUFACTURING PROCESS.
Current openFDA PMA Record#
- Device
- ROTAWIRE GUIDEWIRE WITH WIRECLIP TORQUER
- Applicant
- Boston Scientific Corp
- PMA number
- P900056
- Supplement
- S129
- Product code
- MCX
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Decision date
- 2013-12-15
- Decision code
- OK30
- Date received
- 2013-11-21
- Supplement type
- 30-Day Notice
- Approval order statement
- REMOVAL OF 34 OF THE 48 QUALITY INSPECTIONS WITHIN THE ROTAWIRE GUIDEWIRE MANUFACTURING PROCESS.