Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• 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 Blvd.; 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
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
APPROVAL FOR A MANUFACTURING SITE LOCATED AT DAVOL, INC., IN WOBURN, MASSACHUSETTS.