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: POSTERIOR CHAMBER INTROCULAR LENSES
• Generic Name: intraocular lens
• Regulation Number: 886.3600
• Applicant: CARL ZEISS MEDITEC AG; 5160 Hacienda Drive; Dublin, CA 94568
• PMA Number: P830056
• Supplement Number: S077
• Date Received: 05/31/1996
• Decision Date: 08/01/1996
• Withdrawal Date: 10/12/2006
• Product Code: HQL
• Advisory Committee: Ophthalmic
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement  
APPROVAL FOR A MANUFACTURING SITE LOCATED AT MENTOR CARIBE, LOT 2 JIBARO INDUSTRIAL PARK, CIDRA, PR 00639