• 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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
DeviceMITRACLIP CLIP DELIVERY SYSTEM
Classification Namemitral valve repair devices
Generic Namemitral valve repair devices
Applicant
ABBOTT VASCULAR INC.
4045 campbell avenue
menlo park, CA 94025
PMA NumberP100009
Supplement NumberS005
Date Received05/01/2014
Decision Date05/22/2014
Product Code
NKM[ Registered Establishments with NKM ]
Advisory Committee Cardiovascular
Supplement Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a labeling change that included additions to the list of anticipated events and converting certain procedural caution statements to warning statements.
-
-