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 | NATURAL-KNEE AND NATURAL-KNEE II |
Generic Name | PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, UNCONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER |
Applicant | SULZERMEDICA 9900 SPECTRUM DR. AUSTIN,, TX 78717 |
PMA Number | P940002 |
Supplement Number | S005 |
Date Received | 07/12/2001 |
Decision Date | 08/01/2001 |
Reclassified Date
|
02/01/2003 |
Product Code |
MBD |
Advisory Committee |
Orthopedic |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR CHANGES IN THE MANUFACTURING PROCESS TO FURTHER ASSURE THE CLEANLINESS OF THE DEVICES. |
|
|