PMA P030054S246
- Device
- 1258T AND 1458Q FAMILY OF LEADS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S246
- Product code
- OJX
- Decision date
- 2013-11-14
- 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 MODIFICATION TO THE WELD SHAFT COMPONENT ON 1258T AND 1458Q LEAD FAMILIES.
Current openFDA PMA Record#
- Device
- 1258T AND 1458Q FAMILY OF LEADS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S246
- Product code
- OJX
- Generic name
- Drug eluting permanent left ventricular (lv) pacemaker electrode
- Decision date
- 2013-11-14
- Decision code
- APPR
- Date received
- 2013-06-03
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A MODIFICATION TO THE WELD SHAFT COMPONENT ON 1258T AND 1458Q LEAD FAMILIES.