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 | ENUCLENE(R) OPHTHALMIC SOLUTION |
Generic Name | Solution, cleaning / lubricating, artificial eye |
Applicant | Alcon Research, Ltd. 6201 South Freeway Fort Worth, TX 76134-2099 |
PMA Number | N13787 |
Supplement Number | S003 |
Date Received | 10/25/1999 |
Decision Date | 12/10/1999 |
Withdrawal Date
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07/27/2012 |
Product Code |
MSI |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Express GMP Supplement |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the alternate manufacturing facility located at Alcon Laboratories, Inc., ASPEX Manufacturing Facility, 6201 South Freeway, Fort Worth, TX 76134. |
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