PMA P030054S193
- Device
- EPIC HF/ATLAS + HF/PROMOTE/UNIFY FAMILY OF CRT-DS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S193
- Product code
- LWS
- Decision date
- 2011-08-17
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- APPROVAL FOR MINOR MODIFICATIONS TO THE PATIENT MANUALS PACKAGED WITH THE DEVICES.
Current openFDA PMA Record#
- Device
- EPIC HF/ATLAS + HF/PROMOTE/UNIFY FAMILY OF CRT-DS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S193
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2011-08-17
- Decision code
- APPR
- Date received
- 2011-06-28
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR MINOR MODIFICATIONS TO THE PATIENT MANUALS PACKAGED WITH THE DEVICES.