|
Device | Collastat™ Absorbable Collagen Hemostatic Sponge and Collastat™ Absorbable Collagen Hemostatic Agent – Microfibrillar Fo |
Generic Name | Agent, absorbable hemostatic, collagen based |
Regulation Number | 878.4490 |
Applicant | INTEGRA LIFESCIENCES CORPORATION 311 ENTERPRISE DR. PLAINSBORO, NJ 08536 |
PMA Number | P810006 |
Supplement Number | S103 |
Date Received | 03/20/2023 |
Decision Date | 04/18/2023 |
Product Code |
LMF |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Address a modification to the reporting language of relevant regulatory standard(s). Other than in the reporting units, the proposed change did not stem from or cause a change to any test methods or product release specifications. A 3-year retrospective analysis of the potential effect of the change did not raise any issues related to past product release decisions, and therefore no future product release issues are predicted by the proposed change. |