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 | C2A-TAPER ACETABULAR SYSTEM |
Generic Name | Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented |
Applicant | Biomet, Inc. P.O. Box 587 Warsaw, IN 46581-0587 |
PMA Number | P050009 |
Supplement Number | S004 |
Date Received | 09/27/2007 |
Decision Date | 04/17/2009 |
Withdrawal Date
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07/23/2015 |
Product Code |
MRA |
Advisory Committee |
Orthopedic |
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 IN THE MATERIAL OF THE INNER POUCH WHICH HOLDS THE STERILE POROUS HIP CUPS, INCLUDING COMPONENTS OF THE DEVICE. |
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