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: PARAPERM O2 CLEAR & BLUE LENS
• Generic Name: Lens, contact (other material) - daily
• Regulation Number: 886.5916
• Applicant: Salvatori Ophthalmics Mfg. Corp.; 6416 Parkland Dr.; Sarasota, FL 34243
• PMA Number: P820062
• Supplement Number: S001
• Date Received: 02/23/1984
• Decision Date: 03/16/1984
• Product Code: HQD
• Advisory Committee: Ophthalmic
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No