|
Device | ST JUDE MEDICAL MECHANICAL HEART VALVE |
Generic Name | HEART-VALVE, MECHANICAL |
Applicant | Abbott Medical 177 County Road B. East St. Paul, MN 55117 |
PMA Number | P810002 |
Supplement Number | S060 |
Date Received | 10/23/2006 |
Decision Date | 11/21/2007 |
Product Code |
LWQ |
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 A CHANGE TO THE SUPPLIER OF THE POLYESTER YARN THAT IS USED IN THE FABRICATION OF: 1) THE KNITTED POLYESTER TUBULAR FABRIC THAT IS THE SOURCE MATERIAL FROM THE ST. JUDE MEDICAL MECHANICAL HEART VALVE SEWING CUFFS, AND 2) THE HEMASHIELD BOVINE COLLAGEN SEALED WOVEN POLYESTER VASCULAR GRAFT. |