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.
 
DevicePASCAL Precision Transcatheter Valve Repair System (Guide Sheath), PASCAL Precision Transcatheter Valve Repair System (I
Generic NameMitral valve repair devices
ApplicantEdwards Lifesciences, LLC
One Edwards Way
Irvine, CA 92614
PMA NumberP220003
Supplement NumberS010
Date Received05/01/2023
Decision Date05/30/2023
Product Code NKM 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a manufacturing site located at the Edwards Limerick Facility, Edwards Lifesciences Ireland, National Technology Park, Castletroy, Limerick Ireland V9431X5 for the manufacturing of the PASCAL Precision Transcatheter Valve Repair System including the PASCAL Precision implant system (Models 20000IS and 20000ISM) and the PASCAL Precision guide sheath (Model 20000GS).
-
-