PMA P030054S192
- Device
- CONNECTOR SLEEVE ACCESSORY KIT
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S192
- Product code
- NIK
- Decision date
- 2011-08-05
- 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 A CONNECTOR SLEEVE ACCESSORY KIT MODEL EX3151. THE CONNECTOR SLEEVE IS INDICATED FOR USE WITH IS-4 AND DF-4 LEAD CONNECTORS TO FACILITATE THE CONNECTION TO A PACING SYSTEM ANALYZER AT THE TIME OF IMPLANT.
Current openFDA PMA Record#
- Device
- CONNECTOR SLEEVE ACCESSORY KIT
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S192
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2011-08-05
- Decision code
- APPR
- Date received
- 2011-06-20
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A CONNECTOR SLEEVE ACCESSORY KIT MODEL EX3151. THE CONNECTOR SLEEVE IS INDICATED FOR USE WITH IS-4 AND DF-4 LEAD CONNECTORS TO FACILITATE THE CONNECTION TO A PACING SYSTEM ANALYZER AT THE TIME OF IMPLANT.