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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.
Classification Namegases used within eye to place pressure on detached retina
Regulation Number886.4270
PMA NumberP900067
Supplement NumberS003
Date Received12/26/2001
Decision Date01/29/2002
Product Code
LPO[ Registered Establishments with LPO ]
Advisory Committee Ophthalmic
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for labeling modifications to improve the patient's and doctor's knowledge regarding the hazards of using nitrous oxide for a subsequent surgical procedure when gas is still present in the eye.