FDA.reportPublic FDA data

PMA P030054S387

Device
Cardiac Resynchronization Therapy (CRT)
Applicant
ABBOTT MEDICAL
PMA number
P030054
Supplement
S387
Product code
NIK
Decision date
2020-11-20
Generic name
Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Approval order statement
Process improvements and changes associated with the optimized drug release/elution test method for batch release and annual stability for CRT leads MCRD component manufacturing.

Current openFDA PMA Record#

Device
Cardiac Resynchronization Therapy (CRT)
Applicant
ABBOTT MEDICAL
PMA number
P030054
Supplement
S387
Product code
NIK
Generic name
Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Decision date
2020-11-20
Decision code
OK30
Date received
2020-10-21
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Process improvements and changes associated with the optimized drug release/elution test method for batch release and annual stability for CRT leads MCRD component manufacturing.