PMA P030054S245
- Device
- EPIC HF, EPIC + HR, EPIC II HF, EPIC II+ HF, ATLAS HF, ATLAS+HF, ATLAS II +HF, ATLAS, PROMOTE, PROMOTE +
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S245
- Product code
- NIK
- Decision date
- 2013-05-14
- Classification
- Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (crt-d)
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Approval order statement
- ALTERNATE STERILIZATION CYCLE AT THE PUERTO RICO MANUFACTURING FACILITY.
Current openFDA PMA Record#
- Device
- EPIC HF, EPIC + HR, EPIC II HF, EPIC II+ HF, ATLAS HF, ATLAS+HF, ATLAS II +HF, ATLAS, PROMOTE, PROMOTE +
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S245
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2013-05-14
- Decision code
- OK30
- Date received
- 2013-04-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ALTERNATE STERILIZATION CYCLE AT THE PUERTO RICO MANUFACTURING FACILITY.