|
Device | ROTAPRO™ and Rotalink Rotational Atherectomy System |
Generic Name | CATHETER, CORONARY, ATHERECTOMY |
Applicant | Boston Scientific Corp. TWO SCIMED PLACE MAPLE GROVE, MN 55311-1566 |
PMA Number | P900056 |
Supplement Number | S211 |
Date Received | 08/30/2023 |
Decision Date | 09/28/2023 |
Product Code |
MCX |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Replace the current Long Drive Laser with a new Long Drive Laser on the Rotalink Burr Catheter (Rotalink) Handshake Drive Assembly (Long Drive Assembly) manufacturing line. |