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. |
|
Device | SURGICAL SIMPLEX(R) P BONE CEMENT |
Generic Name | BONE CEMENT |
Regulation Number | 888.3027 |
Applicant | HOWMEDICA CORP. 359 VETERANS BLVD. RUTHERFORD, NJ 07070 |
PMA Number | N17003 |
Supplement Number | S004 |
Date Received | 05/21/1993 |
Decision Date | 06/08/1993 |
Reclassified Date
|
10/14/1999 |
Product Code |
LOD |
Advisory Committee |
Orthopedic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
|
|