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.
 
DeviceSNS BOWEL NEUROSTIMULATORS IMPLANTABLE INTERSTIM FAMILY
Generic NameImplanted electrical device intended for treatment of fecal incontinence
Regulation Number876.5270
ApplicantMEDTRONIC NEUROMODULATION
7000 CENTRAL AVENUE NE
MS RCW225
MINNEAPOLIS, MN 55432
PMA NumberP080025
Supplement NumberS071
Date Received05/30/2014
Decision Date06/27/2014
Product Code QON 
Advisory Committee Gastroenterology/Urology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
ADD AN ALTERNATE SUPPLIER FOR A COMPONENT OF THE BATTERY.
-
-