|
Device | Rotablator Rotational Atherectomy System |
Applicant | Boston Scientific Corp. TWO SCIMED PLACE MAPLE GROVE, MN 55311-1566 |
PMA Number | P900056 |
Supplement Number | S209 |
Date Received | 06/27/2023 |
Decision Date | 07/27/2023 |
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 Change to the PLC software/control system for a sterilization chamber at the Boston Scientific Corporation (BSC) Coventry Rhode Island facility |