PMA P030054S242
- Device
- ATLAS+ HF/ATLAS II HF, ATLAS II+ HF, EPIC+, EPIC II HF, EPIC II+HF, PROMOTE, PROMOTE+, PROMOTE, RF, PROMOTE ACCEL, UNIFY
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S242
- Product code
- NIK
- Decision date
- 2013-04-23
- 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 THE USE OF A SECOND SOURCE SUPPLIER FOR ANCHORS USED IN THE FIRMS ICD, CRT-D, PACEMAKER, AND CRT-P DEVICES.
Current openFDA PMA Record#
- Device
- ATLAS+ HF/ATLAS II HF, ATLAS II+ HF, EPIC+, EPIC II HF, EPIC II+HF, PROMOTE, PROMOTE+, PROMOTE, RF, PROMOTE ACCEL, UNIFY
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S242
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2013-04-23
- Decision code
- APPR
- Date received
- 2012-12-11
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR THE USE OF A SECOND SOURCE SUPPLIER FOR ANCHORS USED IN THE FIRMS ICD, CRT-D, PACEMAKER, AND CRT-P DEVICES.