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: DEKLENE(TM)
• Generic Name: Suture, nonabsorbable, synthetic, polyethylene
• Regulation Number: 878.5000
• Applicant: Deknatel, Inc.; 600 Airport Rd.; Fall River, MA 02720
• PMA Number: P810028
• Supplement Number: S005
• Date Received: 09/07/1984
• Decision Date: 12/17/1984
• Product Code: GAT
• Advisory Committee: General & Plastic Surgery
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No