PMA P030054S148
- Device
- PROMOTE, PROMOTE+, PROMOTE ACCEL AND UNIFY CRT-D'S AND LEADS AND MERLIN PROGRAMMER
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S148
- Product code
- NIK
- Decision date
- 2010-06-22
- 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 LABELING CHANGE FROM SJ-4 TO DF-4 FOR ST. JUDE MEDICAL HIGH VOLTAGE LEAD, IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR (ICD) AND CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) PRODUCTS.
Current openFDA PMA Record#
- Device
- PROMOTE, PROMOTE+, PROMOTE ACCEL AND UNIFY CRT-D'S AND LEADS AND MERLIN PROGRAMMER
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S148
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2010-06-22
- Decision code
- APPR
- Date received
- 2010-04-30
- Supplement type
- Real-Time Process
- Approval order statement
- APPROVAL FOR A LABELING CHANGE FROM SJ-4 TO DF-4 FOR ST. JUDE MEDICAL HIGH VOLTAGE LEAD, IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR (ICD) AND CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) PRODUCTS.