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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 62 Results
productcode NIK PMA Number p Decision Date From 1/1/2022 Decision Date To 1/1/2023
 
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Device
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PMA
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crt-d resynchronization devices Boston Scientific Corp. P010012 S559 12/20/2022
momentum crt-d, momentum x4 crt-d, icd inogen crt-... Boston Scientific Corp. P010012 S566 12/20/2022
momentum™ crt-d, momentum, momentum™ x4 crt-d, ino... Boston Scientific Corp. P010012 S565 12/14/2022
cardiac resynchronization therapy defibrillator (c... Boston Scientific Corp. P010012 S560 12/12/2022
amplia mri crt-d, amplia mri quad crt-d, brava crt... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S808 11/22/2022
bi-directional torque wrench model 6628 Boston Scientific Corp. P010012 S558 11/15/2022
amplia mri crt-d, amplia mri quad crt-d, brava crt... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S805 11/03/2022
contak cd, easytrak, livian, cognis and acuity spi... Boston Scientific Corp. P010012 S564 11/02/2022
icd origen crt-d, momentum crt-d, icd inogen crt-d... Boston Scientific Corp. P010012 S562 10/28/2022
amplia mri crt-d, amplia mri quad crt-d, brava crt... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S806 10/25/2022
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