ORTHOPAEDICS AND REHABILITATION DEVICES ADVISORY PANEL
August 9, 2001
PMA for a Metacarpophalangeal Finger Joint Prosthesis
Briefing Information
FOOD AND DRUG ADMINISTRATION
Cover Memo pdf
Device Description and Proposed Indications for Use pdf
Executive Summary pdf
Panel Questions pdf
Pre-Clinical Review Memo, dated July 11, 2001 pdf
Clinical Review Memo, dated July 11, 2001 pdf
Statistical Review Memo, dated July 9, 2001 pdf
Letter dated November 22, 1999 from FDA to Ascension Orthopedics pdf
Filing Letter dated February 23, 2001 from FDA to Ascension Orthopedics pdf
Letter dated May 1, 2001 from FDA to Ascension Orthopedics pdf
SPONSOR
Ascension Orthopedics, Inc.
Disclaimer
The statements contained in this document are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.
Summary of Safety and Effectiveness Data pdf
Proposed Patient Labeling pdf