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 | INTACS PRESCRIPTION INSERTS |
Generic Name | Implant, corneal, refractive |
Applicant | ADDITION TECHNOLOGY 820 OAK CREEK DRIVE LOMBARD, IL 60148 |
PMA Number | P980031 |
Supplement Number | S005 |
Date Received | 05/02/2003 |
Decision Date | 05/30/2003 |
Product Code |
LQE |
Advisory Committee |
Ophthalmic |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement IMPLEMENTING THE OUTSOURCING OF THE INSPECTION, CLEANING AND PACKAGING OPERATIONS FOR INTACS INSERTS TO THE QUALIFIED CONTRACT MANUFACTURER, BIOTEST LABORATORIES, INC. |
|
|