PMA P000057S011
- Device
- Ascension MCP
- Applicant
- Smith & Nephew, Inc.
- PMA number
- P000057
- Supplement
- S011
- Product code
- NEG
- Decision date
- 2019-03-05
- Classification
- Finger Semi-constrained Pyrolytic Carbon Uncemented Prosthesis
- Generic name
- Finger semi-constrained pyrolytic carbon uncemented prosthesis
- Approval order statement
- Approval for labeling changes to the package insert, surgical technique, patient information brochure, and post-operative therapy brochure.
Current openFDA PMA Record#
- Device
- Ascension MCP
- Applicant
- Smith & Nephew, Inc.
- PMA number
- P000057
- Supplement
- S011
- Product code
- NEG
- Generic name
- Finger semi-constrained pyrolytic carbon uncemented prosthesis
- Decision date
- 2019-03-05
- Decision code
- APPR
- Date received
- 2018-10-10
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- Approval for labeling changes to the package insert, surgical technique, patient information brochure, and post-operative therapy brochure.