|
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 | S001 |
Date Received | 05/01/2007 |
Decision Date | 06/06/2007 |
Product Code |
LMG |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE REMOVAL OF THE UROLOGICAL PROCEDURES EXCLUSION FROM THE INDICATIONS STATEMENT. |