PMA P030054S221
- Device
- CRT-D FAMILY OF DEVICES & UNIFY QUADRA FAMILY OF DEVICES
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S221
- Product code
- NIK
- Decision date
- 2012-05-03
- Classification
- Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (crt-d)
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Approval order statement
- IMPLEMENT ST. JUDE MEDICAL DISTRIBUTION AND LABELING SYSTEM (SDLS) FOR ALL SJM CRMD PRODUCTS.
Current openFDA PMA Record#
- Device
- CRT-D FAMILY OF DEVICES & UNIFY QUADRA FAMILY OF DEVICES
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S221
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2012-05-03
- Decision code
- OK30
- Date received
- 2012-04-03
- Supplement type
- 30-Day Notice
- Approval order statement
- IMPLEMENT ST. JUDE MEDICAL DISTRIBUTION AND LABELING SYSTEM (SDLS) FOR ALL SJM CRMD PRODUCTS.