PMA P030054S143
- Device
- QUICKSITE/QUICKFLEX LEADS/EPIC HF/+HF/EPIC II HF/II + HF/ATLAS HF/+ HF/II HF/II + HF/PROMOTE/PROMOTE + ICDS/CRT-DS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S143
- Product code
- NIK
- Decision date
- 2010-01-22
- Classification
- Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (crt-d)
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Approval order statement
- CHANGE IN THE PROCESS WATER SYSTEM MONITORING FREQUENCY AND LOCATIONS AT ARECIBO, PUERTO RICO MANUFACTURING FACILITY.
Current openFDA PMA Record#
- Device
- QUICKSITE/QUICKFLEX LEADS/EPIC HF/+HF/EPIC II HF/II + HF/ATLAS HF/+ HF/II HF/II + HF/PROMOTE/PROMOTE + ICDS/CRT-DS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S143
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2010-01-22
- Decision code
- OK30
- Date received
- 2009-12-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE IN THE PROCESS WATER SYSTEM MONITORING FREQUENCY AND LOCATIONS AT ARECIBO, PUERTO RICO MANUFACTURING FACILITY.