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