PMA P030054S146
- Device
- ST JUDE MEDICAL, MERLIN PSA EX3100 SYSTEM
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S146
- Product code
- NIK
- Decision date
- 2010-05-03
- 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: 1) THE ADDITION OF THE PACING SYSTEMS ANALYZER (PSA) MODEL EX3100. THE MODEL EX3100 ALSO INCLUDES ACCESSORIES: A) MERLIN ANTENNA ADAPTER EX3190; B) MERLIN CABLE ADAPTER EX3170; AND C) MERLIN ¿M¿ ADAPTER EX3180; AND 2) THE ADDITION OF THE MODEL 3330 VERSION 10.1.1 SOFTWARE.
Current openFDA PMA Record#
- Device
- ST JUDE MEDICAL, MERLIN PSA EX3100 SYSTEM
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S146
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2010-05-03
- Decision code
- APPR
- Date received
- 2010-02-05
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR: 1) THE ADDITION OF THE PACING SYSTEMS ANALYZER (PSA) MODEL EX3100. THE MODEL EX3100 ALSO INCLUDES ACCESSORIES: A) MERLIN ANTENNA ADAPTER EX3190; B) MERLIN CABLE ADAPTER EX3170; AND C) MERLIN ¿M¿ ADAPTER EX3180; AND 2) THE ADDITION OF THE MODEL 3330 VERSION 10.1.1 SOFTWARE.