PMA P030054S142
- Device
- QUICKSITE/QUICKFLEX/EPIC HF/+HF/II HF/II +HF/ATLAS HF/ATLAS + HF/ATLAS II HF/ATLAS II + HF/PROMOTE/PROMOTE +
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S142
- Product code
- NIK
- Decision date
- 2011-05-11
- 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 AT ST. JUDE MEDICAL PUERTO RICO LLC LOCATED IN ARECIBO, PUERTO RICO.
Current openFDA PMA Record#
- Device
- QUICKSITE/QUICKFLEX/EPIC HF/+HF/II HF/II +HF/ATLAS HF/ATLAS + HF/ATLAS II HF/ATLAS II + HF/PROMOTE/PROMOTE +
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S142
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2011-05-11
- Decision code
- APPR
- Date received
- 2009-11-25
- 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 AT ST. JUDE MEDICAL PUERTO RICO LLC LOCATED IN ARECIBO, PUERTO RICO.