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 has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceNIT-OCCLUD PDA
Generic NameOCCLUDER, PATENT DUCTUS, ARTERIOSUS
ApplicantPFM MEDICAL, INC
1916 Palomar Oaks Way
SUITE 150
CARLSBAD, CA 92008
PMA NumberP120009
Date Received05/04/2012
Decision Date08/16/2013
Product Code MAE 
Docket Number 13M-0988
Notice Date 08/26/2013
Advisory Committee Cardiovascular
Clinical TrialsNCT00828334
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE NIT-OCCLUD® PDA. THIS DEVICE IS A PERMANENTLY IMPLANTED PROSTHESIS INDICATED FOR PERCUTANEOUS, TRANSCATHETER CLOSURE OF SMALL TO MODERATE SIZE PATENT DUCTUS ARTERIOSUS WITH A MINIMUMANGIOGRAPHIC DIAMETER LESS THAN 4 MM.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S003 
-
-