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: POSTERIOR CHAMBER INTRAOCULAR LENSES
• Classification Name: intraocular lens
• Generic Name: posterior chamber-iol
• Regulation Number: 886.3600
• Applicant: BAUSCH & LOMB, INC.
• PMA Number: P870045
• Supplement Number: S040
• Date Received: 10/29/1998
• Decision Date: 12/28/1998
• Product Code: HQL [ Registered Establishments with HQL ]
• Advisory Committee: Ophthalmic
• Supplement Type: 135 review track for 30-day notice
• Supplement Reason: process change: sterilization
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Approval for use of an alternate sterilization chamber at griffith microscience.