ASCENSION MCP
FDA premarket approval P000057/S003 · decided 2006-07-17
Approval details
- PMA number
- P000057
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ASCENSION MCP
- Generic name
- Finger semi-constrained pyrolytic carbon uncemented prosthesis
- Applicant
- Smith & Nephew, Inc.
- Date received
- 2006-02-06
- Decision date
- 2006-07-17
- Days to decision
- 161 days
- Decision code
- APPR
- Product code
- NEG
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Cordova, TN
- Statement
- APPROVAL TO ADD A SIZE 05 IMPLANT TO THE PRODUCT LINE.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.