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 | PALACOS R BONE CEMENT |
Generic Name | BONE CEMENT |
Regulation Number | 888.3027 |
Applicant | SMITH & NEPHEW RICHARDS, INC. 1450 BROOKS RD. MEMPHIS, TN 38116 |
PMA Number | P810020 |
Supplement Number | S003 |
Date Received | 11/05/1991 |
Decision Date | 02/14/1992 |
Reclassified Date
|
10/14/1999 |
Product Code |
LOD |
Advisory Committee |
Orthopedic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
|
|