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: ELASTIC LENS AND ELASTIMIDE ULTRAVIOLET-ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR LENSES (IOLS)
• Classification Name: intraocular lens
• Generic Name: iol
• Regulation Number: 886.3600
• Applicant: STARR SURGICAL CO.
• PMA Number: P880091
• Supplement Number: S005
• Date Received: 10/03/1995
• Decision Date: 01/18/1996
• Product Code: HQL [ Registered Establishments with HQL ]
• Advisory Committee: Ophthalmic
• Supplement Type: normal 180 day track
• Supplement Reason: process change: manufacturing
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Approval to change the molding parameters.