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: PARAPERM E.W. BLUE RIGID GAS PERMEABLE CONTACT LEN
• Classification Name: lens, contact (other material) - daily
• Generic Name: blue rigid gas permeable contact lens
• Regulation Number: 886.5916
• Applicant: PARAGON OPTICAL CO.
• PMA Number: P850038
• Supplement Number: S007
• Date Received: 05/15/1989
• Decision Date: 12/27/1989
• Product Code: HQD [ Registered Establishments with HQD ]
• Advisory Committee: Ophthalmic
• Supplement Type: normal 180 day track
• Supplement Reason: labeling change - indications
• Expedited Review Granted?: No
• Combination Product: No