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 | S004 |
Date Received | 02/23/2000 |
Decision Date | 10/11/2001 |
Product Code |
LQE |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR 0.275 MM AND 0.325 MM INTACS(TM) AS WELL AS FOR A NEW TRADE NAME, "INTACS(TM) PRESCRIPTION INSERTS." |
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