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: SGP LENS(TM)
• Generic Name: Lens, contact (other material) - daily
• Regulation Number: 886.5916
• Applicant: The Lifestyle Co., Inc.; 712 Ginesi Dr.; Morganville, NJ 07751
• PMA Number: P840055
• Supplement Number: S005
• Date Received: 02/09/1987
• Decision Date: 05/26/1987
• Product Code: HQD
• Advisory Committee: Ophthalmic
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Other
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No