PMA P030054S104
- Device
- ATLAS II HF, ATLAS+ HF, ATLAS II+ HF, EPIC HF, EPIC II HF, EPIC+ HF, EPIC II+ HF, PROMOTE
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S104
- Product code
- NIK
- Decision date
- 2008-12-18
- 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 A MANUFACTURING SITE LOCATED AT ST. JUDE MEDICAL PUERTO RICO, LLC, ARECIBO, PUERTO RICO.
Current openFDA PMA Record#
- Device
- ATLAS II HF, ATLAS+ HF, ATLAS II+ HF, EPIC HF, EPIC II HF, EPIC+ HF, EPIC II+ HF, PROMOTE
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S104
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2008-12-18
- Decision code
- APPR
- Date received
- 2008-09-04
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT ST. JUDE MEDICAL PUERTO RICO, LLC, ARECIBO, PUERTO RICO.