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 Precision 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 | S042 |
Date Received | 03/07/2024 |
Decision Date | 05/02/2024 |
Product Code |
MCX |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement a manufacturing site located at Cardiovascular Systems Incorporated, 14740 Kirby Dr, Houston, TX 77047 for coronary driveshaft, crown, and Precision manufacturing operations |
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