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 | MAVERICK OTW PTCA CATHETER AND QUANTUM MAVERICK OTW PTCA CATHETER |
Generic Name | Catheters, transluminal coronary angioplasty, percutaneous |
Regulation Number | 870.5100 |
Applicant | SCIMED LIFE SYSTEMS, INC. ONE SCIMED PLACE MAPLE GROVE, MN 55311-1566 |
PMA Number | P860019 |
Supplement Number | S228 |
Date Received | 08/28/2008 |
Decision Date | 09/26/2008 |
Reclassified Date
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10/08/2010 |
Product Code |
LOX |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement CHANGE TO THE METHOD THAT IS USED TO CREATE THE PROXIMAL MARKS, THREE WHITE CIRCUMFERENTIAL MARKINGS, LOCATED ON THE SHAFT OF THE CATHETER. |
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