PMA P030054S165
- Device
- EPIC/+/II, ATLAS/+/II, CURRENT/CURRENT+ AND PROMOTE+ FAMILY OF DEVICES
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S165
- Product code
- NIK
- Decision date
- 2010-09-23
- 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 MODIFICATIONS TO THE CONNECTOR BLOCKS INCLUDING THE USE OF METAL INJECTION MOLDING (MIM) AND THE USE OF MP35N AS THE MATERIAL.
Current openFDA PMA Record#
- Device
- EPIC/+/II, ATLAS/+/II, CURRENT/CURRENT+ AND PROMOTE+ FAMILY OF DEVICES
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S165
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2010-09-23
- Decision code
- APPR
- Date received
- 2010-07-26
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR MODIFICATIONS TO THE CONNECTOR BLOCKS INCLUDING THE USE OF METAL INJECTION MOLDING (MIM) AND THE USE OF MP35N AS THE MATERIAL.