PMA P030054S036
- Device
- ST. JUDE MEDICAL EPIC HF, ATLAS + HF, EPIC II HF AND ATLAS II HF CRT-D FAMILIES
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S036
- Product code
- NIK
- Decision date
- 2006-09-29
- Classification
- Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (crt-d)
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Approval order statement
- CHANGE FROM AN ION MILLING PROCESS TO A WET ETCH REMOVAL PROCESS.
Current openFDA PMA Record#
- Device
- ST. JUDE MEDICAL EPIC HF, ATLAS + HF, EPIC II HF AND ATLAS II HF CRT-D FAMILIES
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S036
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2006-09-29
- Decision code
- OK30
- Date received
- 2006-09-07
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE FROM AN ION MILLING PROCESS TO A WET ETCH REMOVAL PROCESS.