|
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 | S007 |
Date Received | 10/19/2007 |
Decision Date | 05/23/2008 |
Withdrawal Date
|
05/30/2014 |
Product Code |
MAF |
Advisory Committee |
Cardiovascular |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR CHANGING THE STERILIZATION LOAD CONFIGURATION AND TEMPERATURE IN THE AERATION CHAMBER FOR NIRFLEX STENTS. |