|
Device | Rotablator™ and ROTAPRO™ Rotational Atherectomy Systems |
Generic Name | CATHETER, CORONARY, ATHERECTOMY |
Applicant | Boston Scientific Corp. TWO SCIMED PLACE MAPLE GROVE, MN 55311-1566 |
PMA Number | P900056 |
Supplement Number | S207 |
Date Received | 04/13/2023 |
Decision Date | 05/10/2023 |
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 aging production molds and update inspection activities for the components. |