|
Device | ROTAPRO Rotational Atherectomy System Console |
Generic Name | CATHETER, CORONARY, ATHERECTOMY |
Applicant | Boston Scientific Corp. TWO SCIMED PLACE MAPLE GROVE, MN 55311-1566 |
PMA Number | P900056 |
Supplement Number | S176 |
Date Received | 03/18/2019 |
Decision Date | 05/02/2019 |
Product Code |
MCX |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a new firmware component that will replace the default firmware on the microcontroller of the ROTAPRO Console. |