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: BIO-SORB ABSORBABLE DUSTING POWDER
• Generic Name: Powder, dusting, surgical
• Applicant: Johnson & Johnson Medical, Inc.; 1 Johnson & Johnson Plz.; New Brunswick, NJ 08933
• PMA Number: N6264
• Supplement Number: S003
• Date Received: 08/21/1985
• Decision Date: 09/10/1985
• Product Code: KGP
• Advisory Committee: General Hospital
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No