|
Device | 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 | S208 |
Date Received | 04/18/2023 |
Decision Date | 07/17/2023 |
Product Code |
MCX |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a new packaging configuration for the ROTAPRO Rotational Atherectomy System. |