PMA P080006S068
- Device
- ATTAIN PERFORMA MODEL 4298 LEFT VENTRICULAR LEAD
- Applicant
- Medtronic, Inc.
- PMA number
- P080006
- Supplement
- S068
- Product code
- OJX
- Decision date
- 2014-08-01
- 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 ATTAIN PERFORMA MODEL 4298 LEFT VENTRICULAR LEAD, INDICATED FOR CHRONIC PACING IN THE LEFT VENTRICLE VIA THE CARDIAC VEIN, WHEN USED WITH A COMPATIBLE MEDTRONIC CARDIAC RESYNCHRONIZATION THERAPY (CRT) SYSTEM.
Current openFDA PMA Record#
- Device
- ATTAIN PERFORMA MODEL 4298 LEFT VENTRICULAR LEAD
- Applicant
- Medtronic, Inc.
- PMA number
- P080006
- Supplement
- S068
- Product code
- OJX
- Generic name
- Drug eluting permanent left ventricular (lv) pacemaker electrode
- Decision date
- 2014-08-01
- Decision code
- APPR
- Date received
- 2014-04-01
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE ATTAIN PERFORMA MODEL 4298 LEFT VENTRICULAR LEAD, INDICATED FOR CHRONIC PACING IN THE LEFT VENTRICLE VIA THE CARDIAC VEIN, WHEN USED WITH A COMPATIBLE MEDTRONIC CARDIAC RESYNCHRONIZATION THERAPY (CRT) SYSTEM.