PMA P030054S202
- Device
- FORTIFY AND VARIOUS FAMILIES OF CURRENT
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S202
- Product code
- NIK
- Decision date
- 2011-11-01
- 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 INTRODUCTION OF THE IS4/DF4 PORT PLUG ACCESSORY MODEL AC-IS4PP FOR USE WITH ALL SJM DF4 OR IS4 HEADER PORTS.
Current openFDA PMA Record#
- Device
- FORTIFY AND VARIOUS FAMILIES OF CURRENT
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S202
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2011-11-01
- Decision code
- APPR
- Date received
- 2011-09-12
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE INTRODUCTION OF THE IS4/DF4 PORT PLUG ACCESSORY MODEL AC-IS4PP FOR USE WITH ALL SJM DF4 OR IS4 HEADER PORTS.