Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• Device: CHROMIC GUT STERILE ABSORBABLE SUTURES
• Generic Name: Suture, absorbable, natural
• Regulation Number: 878.4830
• Applicant: Davis & Geck, Inc.; American Cynamid Company; One Casper St.; Danbury, CT 06810
• PMA Number: N83433
• Supplement Number: S009
• Date Received: 04/12/1978
• Decision Date: 11/23/1981
• Product Code: GAL
• Advisory Committee: General & Plastic Surgery
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No