PMA P940002
- Device
- NATURAL-KNEE AND NATURAL-KNEE II
- Applicant
- Sulzermedica
- PMA number
- P940002
- Supplement
- S005
- Product code
- MBD
- Decision date
- 2001-08-01
- 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 CHANGES IN THE MANUFACTURING PROCESS TO FURTHER ASSURE THE CLEANLINESS OF THE DEVICES.
Current openFDA PMA Record#
- Device
- NATURAL-KNEE AND NATURAL-KNEE II
- Applicant
- Sulzermedica
- PMA number
- P940002
- Supplement
- S005
- Product code
- MBD
- Generic name
- PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, UNCONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER
- Decision date
- 2001-08-01
- Decision code
- APPR
- Date received
- 2001-07-12
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR CHANGES IN THE MANUFACTURING PROCESS TO FURTHER ASSURE THE CLEANLINESS OF THE DEVICES.