Premarket Approval (PMA)

Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.

• Trade Name: COLLACOTE(R),COLLATAPE(R),COLLAPLUG(R), DRESSINGS
• Classification Name: material, dressing, surgical, polylactic acid
• Generic Name: collagen wound dressing
• Applicant: COLLA-TEC, INC.
• PMA Number: P840062
• Supplement Number: S003
• Date Received: 10/17/1991
• Decision Date: 03/27/1992
• Product Code: LPG [ Registered Establishments with LPG ]
• Advisory Committee: General & Plastic Surgery
• Supplement Type: normal 180 day track
• Supplement Reason: labeling change - other
• Expedited Review Granted?: No
• Combination Product: No