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 | USE OF RED PLASTIC PLUG WITH CONCEPT -1 SOLUTION |
Generic Name | Accessories, soft lens products |
Regulation Number | 886.5928 |
Applicant | ADVANCED MEDICAL OPTICS, INC. 2525 DUPONT DR. IRVINE, CA 92612 |
PMA Number | P840066 |
Supplement Number | S034 |
Date Received | 11/20/1996 |
Decision Date | 01/23/1997 |
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 APPROVAL FOR AN ALTERNATE MANUFACTURING SITE FOR THE REFERENCED DEVICE TO BE LOCATED AT ALLERGAN OPTICAL, 8301 MARS DRIVE, WACO, TX 76712 |
|
|