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 | SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT |
Generic Name | BONE CEMENT |
Regulation Number | 888.3027 |
Applicant | HOWMEDICA CORP. 359 VETERANS BLVD. RUTHERFORD, NJ 07070 |
PMA Number | N17004 |
Supplement Number | S008 |
Date Received | 11/18/1996 |
Decision Date | 12/18/1996 |
Reclassified Date
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10/14/1999 |
Product Code |
LOD |
Advisory Committee |
Orthopedic |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR MINOR CHANGES TO PACKAGING AND LABELING OF THE PRODUCT. |
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