- Device
- Ascension MCP
- Applicant
- Smith & Nephew, Inc.
- PMA number
- P000057
- Supplement
- S010
- Product code
- NEG
- Generic name
- Finger semi-constrained pyrolytic carbon uncemented prosthesis
- Decision date
- 2018-06-29
- Decision code
- APPR
- Date received
- 2017-10-03
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a manufacturing site located at Integra Life Sciences Corporation (Integra), 11101 Metric Boulevard, Austin, Texas.