|Trade Name||COLLACOTE COLLATAPE COLLAPLUG ABSORBABLE COLLAGEN WOUND DRESSINGS 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: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the following proposed changes: 1) change in cleaning detergent from metrizyme (formulated enzymatic cleaner) to cip-100 (formulated alkaline cleaner); 2) establishment of an equipment dirty hold time (dht) of 24-hours; 3) utilization of 70% isopropyl alcohol (ipa), as required; 4) utilization of sodium lauryl sulfate (sls), as required; and 5) establishing the use of total organic carbons (tocs) as a method to test for residues.