PMA P940002S002
- Device
- NATURAL-KNEE(R) WITH CSTI(TM)
- Applicant
- Sulzermedica
- PMA number
- P940002
- Supplement
- S002
- Product code
- MBD
- Decision date
- 1997-10-16
- Classification
- Prosthesis, Knee, Patello/femorotibial, Unconstrained, Uncemented, Porous, Coated, Polymer/metal/polymer
- Generic name
- PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, UNCONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER
- Approval order statement
- Approval for another sterilization site located at SteriGenics International, 3125 Wichita Court, Forth Worth, Texas 76140.
Current openFDA PMA Record#
- Device
- NATURAL-KNEE(R) WITH CSTI(TM)
- Applicant
- Sulzermedica
- PMA number
- P940002
- Supplement
- S002
- Product code
- MBD
- Generic name
- PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, UNCONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER
- Decision date
- 1997-10-16
- Decision code
- APPR
- Date received
- 1997-06-17
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for another sterilization site located at SteriGenics International, 3125 Wichita Court, Forth Worth, Texas 76140.