|
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 | S010 |
Date Received | 10/17/1997 |
Decision Date | 11/13/1997 |
Reclassified Date
|
10/14/1999 |
Product Code |
LOD |
Advisory Committee |
Orthopedic |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the elimination of a series of duplicative tests that are performed on the Surgical Simplex(R) P Bone Cement. |