ASCENSION MCP
FDA premarket approval P000057 · decided 2001-11-19
Approval details
- PMA number
- P000057
- Trade name
- ASCENSION MCP
- Generic name
- Finger semi-constrained pyrolytic carbon uncemented prosthesis
- Applicant
- Smith & Nephew, Inc.
- Date received
- 2000-12-29
- Decision date
- 2001-11-19
- Days to decision
- 325 days
- Decision code
- APPR
- Product code
- NEG
- Advisory committee
- Orthopedic
- Expedited review
- Yes
- Location
- Cordova, TN
- Statement
- THIS DEVICE IS INDICATED FOR USE AS A TOTAL JOINT REPLACEMENT OF INDEX, LONG, RING, AND SMALL FINGER METACARPOPHALANGEAL JOINTS THAT EXHIBIT SYMPTOMS OF PAIN, LIMITED MOTION, OR INADEQUATE BONY ALIGNMENT (I.E., SUBLUXATION/DISLOCATION) SECONDRY TO ARTICULAR DESTRUCTION OR DEGENERATIVE DISEASE RELATED TO RHEUMATOID ARTHRITIS, LUPUS ERYTHEMATOSUS, OSTEOARTHRITIS, OR POST TRAUMATIC ARTHRITIS WHERE SOFT TISSUE RECONSTRUCTION CAN PROVIDE ADEQUATE STABILIZATION.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.