|
Device | DIAMONDBACK 360 Coronary Orbital Atherectomy System (OAS) |
Generic Name | CATHETER, CORONARY, ATHERECTOMY |
Applicant | CARDIOVASCULAR SYSTEMS, INC. 651 CAMPUS DR MINNEAPOLIS, MN 55211 |
PMA Number | P130005 |
Supplement Number | S031 |
Date Received | 11/13/2020 |
Decision Date | 12/10/2020 |
Product Code |
MCX |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Clarifications made to the instructions for use. |