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 UV-ABSORBING COLLAMER FOLDABLE 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: S004
• Date Received: 05/24/2004
• Decision Date: 06/23/2004
• Product Code: HQL [ Registered Establishments with HQL ]
• Advisory Committee: Ophthalmic
• Supplement Type: Special Supplement
• Supplement Reason: labeling change - instructions
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Approval to modify the package insert.