Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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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 | S032 |
Date Received | 12/18/2020 |
Decision Date | 01/14/2021 |
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 | Yes |
Approval Order Statement New sterilization cycle with a mixed sterilization load using Chamber 12 at the Minneapolis, MN sterilization facility and Chambers 1 & 4 at the El Paso, TX sterilization facility. |
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