PMA P030054S218
- Device
- VARIOUS FAMILIES OF EPIC, ATLAS, PROMOTE, UNIFY CRT-D'S
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S218
- Product code
- NIK
- Decision date
- 2012-04-13
- Classification
- Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (crt-d)
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Approval order statement
- APPROVAL FOR IMPLEMENTING PALLADIUM-IRIDIUM (PD-IR) ALLOY WIRE AS AN ALTERNATE TO THE EXISTING PLATINUM-IRIDIUM (PT-IR) ALLOY FEEDTHRU WIRE IN ST. JUDE MEDICAL HIGH AND LOW VOLTAGE PULSE GENERATORS.
Current openFDA PMA Record#
- Device
- VARIOUS FAMILIES OF EPIC, ATLAS, PROMOTE, UNIFY CRT-D'S
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S218
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2012-04-13
- Decision code
- APPR
- Date received
- 2012-02-22
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR IMPLEMENTING PALLADIUM-IRIDIUM (PD-IR) ALLOY WIRE AS AN ALTERNATE TO THE EXISTING PLATINUM-IRIDIUM (PT-IR) ALLOY FEEDTHRU WIRE IN ST. JUDE MEDICAL HIGH AND LOW VOLTAGE PULSE GENERATORS.