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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameIPAFLUOROFOCON A AND B
Classification Namelens, contact (other material) - daily
Generic Nameextended wear contact lens
Regulation Number886.5916
ApplicantPOLYMER TECHNOLOGY CORP.
PMA NumberP860022
Supplement NumberS050
Date Received02/20/1998
Decision Date03/31/1998
Product Code
HQD[ Registered Establishments with HQD ]
Advisory Committee Ophthalmic
Supplement Type 30-Day Supplement
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the three additional finishing laboratories listed to become additional manufacturers and distributors of the device:premier contact lens, 111 28th avenue south, nashville, tn 37212 and premier contact lens, 3614 s. Perkins, memphis, tn 38118.
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