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.
 
DeviceTHINPREP 2000 SYSTEM
Generic NameProcessor, cervical cytology slide, automated
ApplicantHOLOGIC, INC.
250 Campus Drive
Marlborough, MA 01752
PMA NumberP950039
Supplement NumberS011
Date Received10/31/2003
Decision Date02/09/2004
Product Code MKQ 
Advisory Committee Pathology
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 AN ADDITIONAL MANUFACTURING SITE FOR THE FILTER MANUFACTURING PROCESS. THE SITE IS LOCATED AT CYTYC NEW HAMPSHIRE, LONDONDERRY, NEW HAMPSHIRE.
-
-