PMA P030054S007
- Device
- ATLAS AND ATLAS+ IMPLANTABLE CARDIOVERTER DEFIBRILLATORS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S007
- Product code
- NIK
- Decision date
- 2005-06-17
- 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 ICD FIRMWARE VERSION 6.6.7 FOR EPIC MODELS V-233, V-239, V-239T, V-196, V-196T, V-338, V-337, EPIC PLUS MODELS V-236, V-196, ATLAS AND ATLAS PLUS MODELS V-242, V243, V-193, V-193C, V340, V-343; AND MODEL 3307 PROGRAMMER SOFTWARE VERSION 4.8.5.
Current openFDA PMA Record#
- Device
- ATLAS AND ATLAS+ IMPLANTABLE CARDIOVERTER DEFIBRILLATORS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S007
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2005-06-17
- Decision code
- APPR
- Date received
- 2005-04-12
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE ICD FIRMWARE VERSION 6.6.7 FOR EPIC MODELS V-233, V-239, V-239T, V-196, V-196T, V-338, V-337, EPIC PLUS MODELS V-236, V-196, ATLAS AND ATLAS PLUS MODELS V-242, V243, V-193, V-193C, V340, V-343; AND MODEL 3307 PROGRAMMER SOFTWARE VERSION 4.8.5.