|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||GYNECARE INTERCEED ABSORBABLE ADHESION BARRIER|
|Classification Name||barrier, absorable, adhesion|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Expand the existing clean manufacturing environment (cme) area in your san lorenzo manufacturing facility. In addition, the 30-day notice requested to add a second dehumidification chamber as well as add two additional filling banks (to total four filling stations) into this new area.