PMA P030054S155
- Device
- ST. JUDE MEDICAL EPIC HF SYSTEM
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S155
- Product code
- OJX
- Decision date
- 2011-02-11
- Classification
- Drug Eluting Permanent Left Ventricular (lv) Pacemaker Electrode
- Generic name
- Drug eluting permanent left ventricular (lv) pacemaker electrode
- Approval order statement
- APPROVAL FOR A NEW 4.3-4.7 FR SLIT SUTURE SLEEVE ACCESSORY KIT TO BE USED WITH THE APPROVED 1258T QUICKFLEX ¿ LEAD.
Current openFDA PMA Record#
- Device
- ST. JUDE MEDICAL EPIC HF SYSTEM
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S155
- Product code
- OJX
- Generic name
- Drug eluting permanent left ventricular (lv) pacemaker electrode
- Decision date
- 2011-02-11
- Decision code
- APPR
- Date received
- 2010-06-22
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A NEW 4.3-4.7 FR SLIT SUTURE SLEEVE ACCESSORY KIT TO BE USED WITH THE APPROVED 1258T QUICKFLEX ¿ LEAD.