PMA P900056S145
- Device
- ROTAWIRE ELITE GUIDEWIRE
- Applicant
- Boston Scientific Corp
- PMA number
- P900056
- Supplement
- S145
- Product code
- MCX
- Decision date
- 2015-06-19
- Classification
- Catheter, Coronary, Atherectomy
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Approval order statement
- APPROVAL FOR A CORE WIRE VENDOR CHANGE AND THE ASSOCIATED REBRANDING OF THE ROTAWIRE GUIDEWIRE AS THE ROTAWIRE ELITE GUIDEWIRE.
Current openFDA PMA Record#
- Device
- ROTAWIRE ELITE GUIDEWIRE
- Applicant
- Boston Scientific Corp
- PMA number
- P900056
- Supplement
- S145
- Product code
- MCX
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Decision date
- 2015-06-19
- Decision code
- APPR
- Date received
- 2015-03-23
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR A CORE WIRE VENDOR CHANGE AND THE ASSOCIATED REBRANDING OF THE ROTAWIRE GUIDEWIRE AS THE ROTAWIRE ELITE GUIDEWIRE.