|Trade Name||COLLAPLUG ABSORBABLE COLLAGEN WOUND DRESSING FOR DENTAL SURGERY|
|Classification Name||material, dressing, surgical, polylactic acid|
|Generic Name||collagen wound dressing|
|Supplement Type||135 review track for 30-day notice|
|Supplement Reason|| process change - other|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the following proposed changes: 1) a new alkaline detergent for use as a cleaning agent; 2) proposed use of total organic carbons (tocs) as a method to test for residues; 3) swab and rinse recovery factors and a visual limit of detection for medical manufacturing area soil on stainless steel and aluminum surfaces; 4) proposed change in equipment dirty hold times (dhts) for the double density hemostatic dispersion, cross-linking process equipment and the mold filling equipment; and 5) proposed installation and operational qualification of a new ultrasonicator.