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 | CORDIS PRECISE RX NITINOL STENT SYSTEM & PRECISE 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 | S014 |
Date Received | 07/15/2008 |
Decision Date | 08/14/2008 |
Product Code |
NIM |
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 ADDITION OF A SET-UP VERIFICATION STEP IN THE SUPPORT MEMBER ASSEMBLY PROCESS. |
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