PMA P030054S231
- Device
- ATLAS HF,ATLAS II HF,ATLAS II,HF,EPIC,EPIC HF,EPIC,EPIC II HF,EPIC II HF,PROMOTE,PROMOTE,PROMOTE RF,PROMOTE ACCEL,UNIFY
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S231
- Product code
- NIK
- Decision date
- 2012-09-24
- Classification
- Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (crt-d)
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Approval order statement
- REDUCTION IN THE CURE TIME FOR THE ROOM TEMPERATURE VULCANIZED ADHESIVE.
Current openFDA PMA Record#
- Device
- ATLAS HF,ATLAS II HF,ATLAS II,HF,EPIC,EPIC HF,EPIC,EPIC II HF,EPIC II HF,PROMOTE,PROMOTE,PROMOTE RF,PROMOTE ACCEL,UNIFY
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S231
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2012-09-24
- Decision code
- OK30
- Date received
- 2012-08-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- REDUCTION IN THE CURE TIME FOR THE ROOM TEMPERATURE VULCANIZED ADHESIVE.