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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 NameISPAN TM PERFLUOROPROPANE (C3F8)GAS
Classification Namegases used within eye to place pressure on detached retina
Regulation Number886.4270
ApplicantSCOTT MEDICAL PRODUCTS GROUP
PMA NumberP900066
Supplement NumberS002
Date Received08/23/1996
Decision Date09/24/1996
Product Code
LPO[ Registered Establishments with LPO ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to add a 20 gram and a 125 gram aluminum lecture bottle size for the referenced devices.
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