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 | NIRFLEX PREMOUNTED CORONARY STENT SYSTEM |
Generic Name | STENT, CORONARY |
Applicant | MEDINOL LTD. KIRYAT ATIDIM, BLDG. 8 POB 58165 TEL-AVIV 61581 |
PMA Number | P020040 |
Supplement Number | S004 |
Date Received | 01/16/2007 |
Decision Date | 02/15/2007 |
Withdrawal Date
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05/30/2014 |
Product Code |
MAF |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement CHANGE TO THE PCD CONFIGURATION USED DURING THE ETO STERILIZATION PROCESS AND REMOVAL TIMING FOR THE INCUBATION OF THE BIS USED DURING THE ETO STERILIZATION PROCESS. |
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