Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
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.
 
DeviceARISTA AH ABSORRBABLE HEMOSTAT
Generic NameAgent, absorbable hemostatic, non-collagen based
Regulation Number878.4490
ApplicantDavol, Inc.
100 Crossings Blvd.
Warwick, RI 02886
PMA NumberP050038
Supplement NumberS019
Date Received12/13/2013
Decision Date02/27/2014
Product Code LMG 
Advisory Committee General & Plastic Surgery
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A LARGER (18 GRAM) BELLOW CONTAINER FOR THE 5 GRAM ARISTA AH DEVICE AND INCREASES IN THE DIMENSIONS OF THE DEVICE PACKAGING, SPECIFICALLY, THE FOIL AND TYVEK POUCHES AND SHELF AND SHIPPER BOXES.
-
-