PMA P030054S130
- Device
- QUICKFLEX U MODEL 1258T LEAD
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S130
- Product code
- OJX
- Decision date
- 2010-05-10
- Classification
- Drug Eluting Permanent Left Ventricular (lv) Pacemaker Electrode
- Generic name
- Drug eluting permanent left ventricular (lv) pacemaker electrode
- Approval order statement
- APPROVAL FOR THE QUICKFLEX µ MODEL 1258TLEFT VENTRICULAR LEAD.
Current openFDA PMA Record#
- Device
- QUICKFLEX U MODEL 1258T LEAD
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S130
- Product code
- OJX
- Generic name
- Drug eluting permanent left ventricular (lv) pacemaker electrode
- Decision date
- 2010-05-10
- Decision code
- APPR
- Date received
- 2009-07-16
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE QUICKFLEX µ MODEL 1258TLEFT VENTRICULAR LEAD.