PMA P940002S001
- Device
- NATURAL-KNEE(R) WITH CSTI(TM)
- Applicant
- Sulzermedica
- PMA number
- P940002
- Supplement
- S001
- Product code
- MBD
- Decision date
- 1997-04-30
- 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
- APPROVLA FOR POSTAPPROVAL PROTOCOL AND MODIFICATIONS TO YOUR PACKAGE INSERTS
Current openFDA PMA Record#
- Device
- NATURAL-KNEE(R) WITH CSTI(TM)
- Applicant
- Sulzermedica
- PMA number
- P940002
- Supplement
- S001
- Product code
- MBD
- Generic name
- PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, UNCONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER
- Decision date
- 1997-04-30
- Decision code
- APPR
- Date received
- 1997-04-02
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVLA FOR POSTAPPROVAL PROTOCOL AND MODIFICATIONS TO YOUR PACKAGE INSERTS