• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


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.
 
Trade NameMYNXCADENCE AND MYNXGRIP VASCULAR DEVICES
Classification Namedevice, hemostasis, vascular
ApplicantACCESS CLOSURE, INC.
PMA NumberP040044
Supplement NumberS048
Date Received02/22/2013
Decision Date05/17/2013
Product Code
MGB[ Registered Establishments with MGB ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason labeling change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for clarification and simplification of the language used in the instruction for use and removal of the sterilization indicator label from the device pouch for the mynx cadence vascular closure device, 6f/7f mynxgrip vascular closure device, and 5f mynxgrip vascular closure device.
-
-