PMA P030054S156
- Device
- EPIC HF/ATLAS+HF FAMILY OF CRT-DS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S156
- Product code
- NIK
- Decision date
- 2010-07-21
- 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 THE IMPROVEMENT OF THE MANUFACTURE AND QA PROCESS BY INSERTING THE INSPECTIONS TO THE BATTERY WELDING.
Current openFDA PMA Record#
- Device
- EPIC HF/ATLAS+HF FAMILY OF CRT-DS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S156
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2010-07-21
- Decision code
- APPR
- Date received
- 2010-06-24
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR THE IMPROVEMENT OF THE MANUFACTURE AND QA PROCESS BY INSERTING THE INSPECTIONS TO THE BATTERY WELDING.