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. |
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Device | INTACS PRESCRIPTION INSERTS |
Generic Name | Implant, corneal, refractive |
Applicant | ADDITION TECHNOLOGY 820 OAK CREEK DRIVE LOMBARD, IL 60148 |
PMA Number | P980031 |
Supplement Number | S009 |
Date Received | 10/31/2005 |
Decision Date | 11/23/2005 |
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 TRANSFER OF NON-CRITICAL "AS/MANUFACTURED" DIMENSIONAL INSPECTIONS OF WIDTH, SYMMETRY, OUTER DIAMETER, ARC LENGTH, AND DRILL HOLE PLACEMENT FOR MACHINED INTACS PRESCRIPTION INSERTS FROM BIOTEST LABORATORIES TO OCULAR TECHNOLOGY INC. |
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