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: SOFTEC HD INTRAOCULAR LENS
• Generic Name: intraocular lens
• Regulation Number: 886.3600
• Applicant: LENSTEC, INC.; 1765 COMMERCE AVE N; ST. PETERSBURG, FL 33716
• PMA Number: P090022
• Supplement Number: S006
• Date Received: 07/28/2011
• Decision Date: 08/25/2011
• Product Code: HQL
• Advisory Committee: Ophthalmic
• Supplement Type: 30-Day Notice
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement  
USE OF AN ALTERNATIVE SUPPLIER OF THE SILICONE VIAL STOPPER.