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.
 
DeviceMitraClip™ NTR/XTR Clip Delivery System, MitraClip™ G4 Clip Delivery System
Generic NameMitral valve repair devices
ApplicantAbbott Medical
177 Country Road B East
St. Paul, MN 55117
PMA NumberP100009
Supplement NumberS064
Date Received03/15/2024
Decision Date04/09/2024
Product Code NKM 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
use of an additional sterilization line, aeration room, and pre-existing preconditioning room to increase sterilization capacity at the currently approved contract sterilization facility
-
-