• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back to Search Results
Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameBRAVA/ BRAVA QUAD CRT-D, CONCERTO II CRT-D, CONSULTA, MAXIMO II, PROTECTA, PROTECTA XT ,VIVA QUAD S/XT/S CRT-D'S
Generic Namecardiac resynchronization therapy
ApplicantMEDTRONIC, INC.
PMA NumberP010031
Supplement NumberS454
Date Received07/15/2014
Decision Date07/22/2014
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Modification on laser seam welder equipment at a final device manufacturing facility for the devices.
-
-