PMA P030054S072
- Device
- EPIC HF CRT-D AND QUICKSITE & QUICKFLEX LEADS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S072
- Product code
- NIK
- Decision date
- 2008-05-16
- 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 STERI-TECH, INC., SALINAS, PUERTO RICO FOR ETHYLENE OXIDE STERILIZATION OF THE PACEMAKERS, ICDS AND LEADS.
Current openFDA PMA Record#
- Device
- EPIC HF CRT-D AND QUICKSITE & QUICKFLEX LEADS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S072
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2008-05-16
- Decision code
- APPR
- Date received
- 2007-10-19
- 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 STERI-TECH, INC., SALINAS, PUERTO RICO FOR ETHYLENE OXIDE STERILIZATION OF THE PACEMAKERS, ICDS AND LEADS.