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 | CLARIS(R) CLEANING AND SOAKING SOLUTION |
Generic Name | Accessories, soft lens products |
Regulation Number | 886.5928 |
Applicant | ADVANCED MEDICAL OPTICS, INC. 2525 DUPONT DR. IRVINE, CA 92612 |
PMA Number | P870023 |
Supplement Number | S007 |
Date Received | 03/01/1996 |
Decision Date | 07/12/1996 |
Product Code |
LPN |
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 ALTERNATE MANUFACTURING SITE:ALLERGAN OPTICAL, 8301 MARS DRIVE, WACO, TEXAS 76712. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CLARIS CLEANING AND SOAKING SOLUTION |
|
|