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: ELASTIC AND ELASTIMIDE ULTRAVIOLET-ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR LENSES
• Generic Name: LENS, INTRAOCULAR, TORIC OPTICS
• Regulation Number: 886.3600
• Applicant: Staar Surgical Co.; 1911 Walker Ave.; Monrovia, CA 91016
• PMA Number: P880091
• Supplement Number: S015
• Date Received: 09/17/1998
• Decision Date: 03/15/1999
• Product Code: MJP
• Advisory Committee: Ophthalmic
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval for a modification to the manufacturing process.