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.
 
DeviceMetriQ Irrigation Pump
Generic Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
ApplicantBoston Scientific Corp.
150 BAYTECH DRIVE
SAN JOSE, CA 95134
PMA NumberP150005
Supplement NumberS013
Date Received11/17/2016
Decision Date04/20/2017
Product Code OAD 
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
Approval Order Statement  
Approval for a manufacturing site located at Boston Scientific Corporation, 150 Baytech Drive, San Jose, California, 95134.
-
-