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
-
1 to 10 of 18 Results
productcode NIK PMA Number p Decision Date From 1/1/2024 Decision Date To 1/1/2025
 
 1 
 2 
 > 
Records per Page
New Search  
Export all 18 Records to ExcelExport to Excel HelpHelp
Device
Sort by Device [A-Z]
Sort by Device [Z-A]
Applicant
Sort by Applicant [A-Z]
Sort by Applicant [Z-A]
PMA
Number
Sort by PMA Number [0-9]
Sort by PMA Number [9-0]
Decision
Date
Sort by Decision Date [0-9]
Sort by Decision Date [9-0]
Unify, Unify Quadra, Unify Assura, Quadra Assura, ... Abbott Medical P030054 S421 05/22/2024
Entrant CRT-D, Gallant CRT D, Neutrino NxT HF CRT-... Abbott Medical P030054 S420 05/14/2024
COGNIS, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN,... Boston Scientific Corp. P010012 S580 04/30/2024
Cobalt MRI CRT-D, CobaltXT MRI CRT-D, Crome MRI CR... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S849 03/04/2024
Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI C... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S850 03/01/2024
CareLink SmartSync Cobalt, Crome App, Cobalt XT MR... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S856 04/26/2024
Butylated Hydroxytoluene (BHT) Boston Scientific Corp. P010012 S579 01/03/2024
Avant, Neutrino NxT, Gallant, Entrant, Unify, Unif... Abbott Medical P030054 S417 02/21/2024
Avant, Gallant, Entrant, Neutrino NxT Family of CR... Abbott Medical P030054 S419 05/01/2024
Amplia MRI CRT-D,Amplia MRI Quad CRTD, Brava CRT-D... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S852 04/04/2024
-
-