|
Device | Rotablator™and ROTAPRO™ 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 | S200 |
Date Received | 04/11/2022 |
Decision Date | 09/02/2022 |
Product Code |
MCX |
Advisory Committee |
Cardiovascular |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for changes to incoming inspection activities and a supplier change. |