|
Device | ARISTA AH ABSORBABLE HEMOSTAT |
Generic Name | Agent, absorbable hemostatic, non-collagen based |
Regulation Number | 878.4490 |
Applicant | Davol, Inc. 100 Crossings Boulevard Warwick, RI 02886 |
PMA Number | P050038 |
Supplement Number | S011 |
Date Received | 02/22/2012 |
Decision Date | 03/23/2012 |
Product Code |
LMG |
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 ADDITION OF AN ALTERNATE SUPPLIER OF A CRITICAL COMPONENT USED IN THE MANUFACTURE OF THE ARISTA AH ABSORBABLE HEMOSTAT. |