PMA P030054S248
- Device
- UNIFY AND UNIFY QUANDRA FAMILY OF CRT-DS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S248
- Product code
- NIK
- Decision date
- 2013-06-12
- Classification
- Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (crt-d)
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Approval order statement
- ST. JUDE MEDICAL CRMDSYLMAR CA 91342 MODIFICATION OF THE HYBRID POST BURN-IN ATE TESTING FOR THE DEVICES.
Current openFDA PMA Record#
- Device
- UNIFY AND UNIFY QUANDRA FAMILY OF CRT-DS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S248
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2013-06-12
- Decision code
- OK30
- Date received
- 2013-05-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ST. JUDE MEDICAL CRMDSYLMAR CA 91342 MODIFICATION OF THE HYBRID POST BURN-IN ATE TESTING FOR THE DEVICES.