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 |
Generic Name | CATHETER, CORONARY, ATHERECTOMY |
Applicant | CARDIOVASCULAR SYSTEMS, INC. 651 CAMPUS DR MINNEAPOLIS, MN 55211 |
PMA Number | P130005 |
Supplement Number | S012 |
Date Received | 03/23/2016 |
Decision Date | 10/26/2016 |
Product Code |
MCX |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval to add heat/light stabilizers to the PEBAX used to construct the Saline Sheaths of the OAD. |
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