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: STAAR SURGICAL COLLAMER INTRAOCULAR LENSES
• Classification Name: intraocular lens
• Generic Name: uv-absorbing posterior chamber iol
• Regulation Number: 886.3600
• Applicant: STAAR SURGICAL CO.
• PMA Number: P990013
• Supplement Number: S028
• Date Received: 07/27/2010
• Decision Date: 08/26/2010
• Product Code: HQL [ Registered Establishments with HQL ]
• Advisory Committee: Ophthalmic
• Supplement Type: 30-day notice
• Supplement Reason: process change: packaging
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Change to the aluminum crimp caps used as part of the packaging for the iols.