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: MEMORY LENS ULTRAVIOLET-ABSORBING HYDROPHILIC POSTERIOR CHAMBER IOL
• Generic Name: intraocular lens
• Regulation Number: 886.3600
• Applicant: Ioltech, S.A.; 64 Schoosett St.; Penbroke, MA 02359
• PMA Number: P960036
• Supplement Number: S002
• Date Received: 07/17/2000
• Decision Date: 08/25/2000
• Withdrawal Date: 10/12/2006
• Product Code: HQL
• Advisory Committee: Ophthalmic
• Supplement Type: Normal 180 Day Track
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
APPROVAL FOR THE MANUFACTURING CHANGES THAT WERE IMPLEMENTED AS A RESULT OF THE VOLUNTARY RECALL.