|
Device | ARISTA AH ABSORBABLE HEMOSTAT AND FLEXTIP APPLICATORS |
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 | S022 |
Date Received | 04/29/2014 |
Decision Date | 09/24/2014 |
Product Code |
LMG |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A MANUFACTURING SITE LOCATED AT DAVOL, INC., IN WOBURN, MASSACHUSETTS. |