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.
 
DeviceeCoin implanted tibial stimulator
Generic NameStimulator, tibial, electrical, implantable, for urinary incontinence
ApplicantBoston Scientific Corporation
100 Boston Scientific Way
Marlborough, MA 01752
PMA NumberP200036
Supplement NumberS005
Date Received12/15/2022
Decision Date03/13/2023
Product Code QPT 
Advisory Committee Gastroenterology/Urology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a modification to the printed circuit board assembly component of the External Controller, a reduction in the number of External Controller and its associated accessories (adaptors, radios, and antennas) included in the kit to one, and changes to the External Controller labeling (i.e., minor clarifications and to reflect the change in kit components).
-
-