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.
 
DeviceMEDSTREAM PROGRAMMABLE INFUSION PUMP
Generic NamePump, infusion, implanted, programmable
ApplicantIntera Oncology
180 Wells Ave., Suite 300a
Newton, MA 02459
PMA NumberP890055
Supplement NumberS056
Date Received05/01/2014
Decision Date07/30/2014
Product Code LKK 
Advisory Committee General Hospital
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 TO REPLACE ELECTRICAL GAP WELDING OR LASER WELDING OF THE MEDSTREAM PUMP¿S ELECTRICAL COMPONENTS ON THE PRINTED CIRCUIT BOARD (PCB) WITH A THERMOBRAZING PROCESS, MODIFY THE EXTREMITY OF THE FLEX FLS, FLEX RF, AND BATTERY RIBBON COMPONENT TO INCLUDE APERTURES, AND ELIMINATE THE CURRENT IN-PROCESS MICRO PULL TEST FOR EACH CONNECTION.
-
-