|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 Name||INTERCEED TC7 ABSORBABLE ADHESION BARRIER|
|Classification Name||barrier, absorable, adhesion|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - other|
|Expedited Review Granted?|| 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.