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.
 
DeviceBulkamid Urethral Bulking System
Generic NameAGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
ApplicantBoston Scientific Corporation
100 Boston Scientfic Way
Marlborough, MA 01752
PMA NumberP170023
Supplement NumberS003
Date Received08/13/2020
Decision Date10/22/2020
Product Code LNM 
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 changes in the primary packaging of Bulkamid Urethral Bulking System (Bulkamid Rotatable Sheath), upgrade to the corresponding process equipment, and replacement of the pouch sealing machine
-
-