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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 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.
 
DeviceINTERCEED (TC7) ABSORBABLE ADHESION BARRIER
Classification Namebarrier, absorable, adhesion
Generic Namebarrier, absorable, adhesion
Applicant
ETHICON, INC.
route 22 west
p.o. box 151
somerville, NJ 08876-0151
PMA NumberP880047
Supplement NumberS008
Date Received09/04/2003
Decision Date10/21/2003
Product Code
MCN[ Registered Establishments with MCN ]
Advisory Committee Obstetrics/Gynecology
Supplement Typenormal 180 day track no user fee
Supplement Reason express gmp supplement
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR A STERILIZATION FACILITY LOCATED AT STERIS-ISOMEDIX SERVICES, VEGA ALTA, PUERTO RICO.
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