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Device | CORDIS PRECISE NITINOL STENT SYSTEM & RX NITINOL STENT & PRO RX NITINOL STENT SYSTEM |
Generic Name | STENT, CAROTID |
Applicant | Cordis US Corporation 14201 N.W. 60th Avenue Miami Lakes, FL 33014 |
PMA Number | P030047 |
Supplement Number | S011 |
Date Received | 02/05/2008 |
Decision Date | 09/30/2008 |
Product Code |
NIM |
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 REDUCING THE SAMPLE SIZE FOR THE FOLLOWING PROCESSES: 1) THE FUSING OPERATION FOR ALL PRECISE DEVICES AND THE SEALING OPERATION FOR PRECISE RX; AND 2) THE BONDING PROCESS OF THE PRECISE RX AND PRECISE PRO RX SUPPORT MEMBER/WIRE LUMEN SUBASSEMBLY. |