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.
 
DeviceCOLLAGRAFT STRIP BONE GRAFT MATRIX
Generic NameFiller, bone void, non-osteoinduction
ApplicantNeucoll, Inc.
105 Cooper Ct.
Los Gatos, CA 95032
PMA NumberP900039
Supplement NumberS010
Date Received11/23/1998
Decision Date12/07/1998
Reclassified Date06/02/2003
Product Code MBS 
Advisory Committee Orthopedic
Supplement TypeReal-Time Process
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for changes to your manufacturing process. These changes involve 1) moving some of the manufacturing operations currently performed in a Class 100 room to a "controlled" environment that provides the equivalent of a Class 10,000 environment, 2) increasing the "hold" time between the remisturization and irradiation processes, and 3) eliminating both the protein concentration assay for past homogenate mixing and the LAL pyrogenicity assay, as described in the supplement.
-
-