PMA P030054S337
- Device
- Promote+ CD3211-36, CD3211-36Q; Unify CD3231-40, CD3231-40Q; Unify Quadra CD3249-40, CD3249-40Q; Unify Assura CD3257-40,
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S337
- Product code
- NIK
- Decision date
- 2017-10-16
- Classification
- Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (crt-d)
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Approval order statement
- Automation of the tray packaging inspection process to ensure the required components are in the tray.
Current openFDA PMA Record#
- Device
- Promote+ CD3211-36, CD3211-36Q; Unify CD3231-40, CD3231-40Q; Unify Quadra CD3249-40, CD3249-40Q; Unify Assura CD3257-40,
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S337
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2017-10-16
- Decision code
- OK30
- Date received
- 2017-09-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Automation of the tray packaging inspection process to ensure the required components are in the tray.