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.
 
DeviceOPTIMIZER Smart System
Generic NameImplantable pulse generator
ApplicantImpulse Dynamics (USA), Inc.
50 Lake Center Executive Parkway
401 Route 73N, Bldg. 50 ste 100
Marlton, NJ 08053
PMA NumberP180036
Supplement NumberS002
Date Received06/21/2019
Decision Date08/13/2019
Product Code QFV 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for changes to the circuit components of the OPTIMIZER Smart IPG to improve manufacturability, robustness, and reliability.
-
-