PMA P030054S180
- Device
- EPIC HF/ATLAS+HF/PROMOTE/UNIFY FAMILIES OF CRT-DS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S180
- Product code
- NIK
- Decision date
- 2011-08-02
- 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 ADDITIONAL MANUFACTURING SCREENING TESTS FOR A DEVICE COMPONENT.
Current openFDA PMA Record#
- Device
- EPIC HF/ATLAS+HF/PROMOTE/UNIFY FAMILIES OF CRT-DS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S180
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2011-08-02
- Decision code
- APPR
- Date received
- 2011-03-09
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR ADDITIONAL MANUFACTURING SCREENING TESTS FOR A DEVICE COMPONENT.