• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back to Search Results
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 NameINTERCEED TC7 ABSORBABLE ADHESION BARRIER
Classification Namebarrier, absorable, adhesion
ApplicantETHICON, INC.
PMA NumberP880047
Supplement NumberS005
Date Received12/03/1997
Decision Date02/09/1998
Product Code
MCN[ Registered Establishments with MCN ]
Advisory Committee Obstetrics/Gynecology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for 1)the addition of an alternate 60 denier yarn constructed of 24 filaments instead of 18 filaments, and 2) the addition of the alternate final product release site of somerville, new jersey. The device, as modified, will be marketed under the trade name interceed*(tc7) and is indicated as an adhesion barrier to be used as an adjuvant to gynecologic pelvic surgery.
-
-