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.
 
DeviceREALIZE ADJUSTABLE GASTRIC BANDS WITH INJECTION PORT & APPLIER
Generic NameIMPLANT, INTRAGASTRIC FOR MORBID OBESITY
ApplicantObtech Medical GmbH
Landis And Gyr Strasse 1
Zug CH-6300
PMA NumberP070009
Supplement NumberS013
Date Received02/08/2011
Decision Date03/31/2011
Withdrawal Date03/17/2017
Product Code LTI 
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 DEVICE CHANGE TO MODIFY THE SILICONE MATERIAL USED FOR THE INJECTION PORT SEPTUM AND INJECTION PORT CONNECTOR SLEEVE COMPONENTS, ALONG WITH A MINOR ASSOCIATED LABELING MODIFICATION.
-
-