Premarket Approval (PMA)

• Trade Name: SEREINE WETTING & SOAKING SOLU. (NEW PRESERVATIVE)
• Classification Name: accessories, soft lens products
• Generic Name: wetting and soaking solution for rgp lenses
• Regulation Number: 886.5928
• Applicant: TRP COMPANY
• PMA Number: P870051
• Supplement Number: S007
• Date Received: 04/22/1997
• Decision Date: 10/15/1997
• Product Code: LPN [ Registered Establishments with LPN ]
• Advisory Committee: Ophthalmic
• Supplement Type: normal 180 day track
• Supplement Reason: labeling change - indications
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Approval for an expansion of the indications for use of the subject devices to include fluorosilicone acrylate rigid gas permeable contact lenses.