PMA P030054S170
- Device
- QUICKFLEX FAMILY OF LEFT HEART LEADS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S170
- Product code
- OJX
- Decision date
- 2010-09-24
- Classification
- Drug Eluting Permanent Left Ventricular (lv) Pacemaker Electrode
- Generic name
- Drug eluting permanent left ventricular (lv) pacemaker electrode
- Approval order statement
- APPROVAL FOR AN INCREASE IN INNER DIAMETER OF THE STYLET STOP FEATURE OF THE ELECTRODE COMPONENT OF THE DEVICE.
Current openFDA PMA Record#
- Device
- QUICKFLEX FAMILY OF LEFT HEART LEADS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S170
- Product code
- OJX
- Generic name
- Drug eluting permanent left ventricular (lv) pacemaker electrode
- Decision date
- 2010-09-24
- Decision code
- APPR
- Date received
- 2010-08-20
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR AN INCREASE IN INNER DIAMETER OF THE STYLET STOP FEATURE OF THE ELECTRODE COMPONENT OF THE DEVICE.