PMA P000057S002
- Device
- ASCENSION MCP
- Applicant
- Smith & Nephew, Inc.
- PMA number
- P000057
- Supplement
- S002
- Product code
- NEG
- Decision date
- 2003-08-11
- Classification
- Finger Semi-constrained Pyrolytic Carbon Uncemented Prosthesis
- Generic name
- Finger semi-constrained pyrolytic carbon uncemented prosthesis
- Approval order statement
- APPROVAL TO EXTEND THE SHELF LIFE EXPIRATION DATE FROM 2 YEARS TO 4 YEARS.
Current openFDA PMA Record#
- Device
- ASCENSION MCP
- Applicant
- Smith & Nephew, Inc.
- PMA number
- P000057
- Supplement
- S002
- Product code
- NEG
- Generic name
- Finger semi-constrained pyrolytic carbon uncemented prosthesis
- Decision date
- 2003-08-11
- Decision code
- APPR
- Date received
- 2003-07-02
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL TO EXTEND THE SHELF LIFE EXPIRATION DATE FROM 2 YEARS TO 4 YEARS.