|
Device | INTACS PRESCRIPTION INSERTS |
Generic Name | Implant, corneal, refractive |
Applicant | ADDITION TECHNOLOGY 820 OAK CREEK DRIVE LOMBARD, IL 60148 |
PMA Number | P980031 |
Supplement Number | S007 |
Date Received | 05/19/2004 |
Decision Date | 08/21/2007 |
Product Code |
LQE |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR PACKAGING OPERATIONS FOR THE INTACS PRESCRIPTION INSERTS TO BE TRANSFERRED TO THE SUNNYVALE, CALIFORNIA FACILITY. |