PMA P030054S001
- Device
- ST. JUDE MEDICAL EPIC HF DEFIBRILLATOR MODEL V-337, ST. JUDE MEDICAL ATLAS+ HF DEFIBRILLATOR MODEL V-343
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S001
- Product code
- NIK
- Decision date
- 2004-11-17
- 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 ADDITION OF A PROGRAMMABLE INTERVENTRICULAR PACE DELAY FEATURE TO THE CURRENTLY MARKET-APPROVED CRT-D DEVICES.
Current openFDA PMA Record#
- Device
- ST. JUDE MEDICAL EPIC HF DEFIBRILLATOR MODEL V-337, ST. JUDE MEDICAL ATLAS+ HF DEFIBRILLATOR MODEL V-343
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S001
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2004-11-17
- Decision code
- APPR
- Date received
- 2004-07-01
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE ADDITION OF A PROGRAMMABLE INTERVENTRICULAR PACE DELAY FEATURE TO THE CURRENTLY MARKET-APPROVED CRT-D DEVICES.