|
Device | ROTAPRO Advancer; ROTAPRO; ROTAPRO Console |
Generic Name | CATHETER, CORONARY, ATHERECTOMY |
Applicant | Boston Scientific Corp. TWO SCIMED PLACE MAPLE GROVE, MN 55311-1566 |
PMA Number | P900056 |
Supplement Number | S166 |
Date Received | 09/07/2017 |
Decision Date | 03/19/2018 |
Product Code |
MCX |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval to modify and rebrand the Rotablator Rotational Atherectomy system devices and accessories. |