PMA P030054S280
- Device
- UNIFY,UNIFY ASSURA,UNIFY QUADRA,QUADRA ASSURA CRT-DS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S280
- Product code
- NIK
- Decision date
- 2015-01-28
- 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 MODIFIED DESIGN OF INSULATING TAPE.
Current openFDA PMA Record#
- Device
- UNIFY,UNIFY ASSURA,UNIFY QUADRA,QUADRA ASSURA CRT-DS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S280
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2015-01-28
- Decision code
- APPR
- Date received
- 2014-12-08
- Supplement type
- Real-Time Process
- Approval order statement
- APPROVAL FOR MODIFIED DESIGN OF INSULATING TAPE.