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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceLINCOFF-DESIGN SCLERAL BUCKLING BALLOON CATHETER
Classification Namecatheter, balloon for retinal reattachment
Generic Namecatheter, balloon for retinal reattachment
Applicant
BAUSCH & LOMB
50 technology drive
irvine, CA 92618
PMA NumberP820009
Date Received02/22/1982
Decision Date10/25/1983
Withdrawal Date 01/23/2015
Product Code
LOG
Docket Number 83M-0370
Notice Date 11/21/1983
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination Product No
Supplements: S001 S003 
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