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.
 
DevicePURE-DENT B851 ABSORBABLE DUSTING POWDER
Generic NamePowder, dusting, surgical
ApplicantGRAIN PROCESSING CORP.
1600 OREGON ST.
MUSCATINE, IA 52761
PMA NumberP890070
Supplement NumberS005
Date Received02/17/2011
Decision Date10/07/2011
Withdrawal Date 12/28/2015
Product Code KGP 
Advisory Committee General Hospital
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A MANUFACTURING SITE LOCATED AT PACMOORE PROCESS TECHNOLOGIES, LLC. IN MOORESVILLE, INDIANA.
-
-