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: SILIKON 1000
• Classification Name: fluid, intraocular
• Generic Name: silicone oil 1000cp
• Regulation Number: 886.4275
• Applicant: ALCON
• PMA Number: P950008
• Supplement Number: S008
• Date Received: 02/11/2011
• Decision Date: 03/10/2011
• Product Code: LWL [ Registered Establishments with LWL ]
• Advisory Committee: Ophthalmic
• Supplement Type: 30-day notice
• Supplement Reason: process change: sterilization
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Establish iso classification for two controlled environment areas.