PMA P080006S156
- Device
- Attain Ability Straight Left Ventricular Lead
- Applicant
- Medtronic, Inc.
- PMA number
- P080006
- Supplement
- S156
- Product code
- OJX
- Decision date
- 2021-02-09
- Generic name
- Drug eluting permanent left ventricular (lv) pacemaker electrode
- Approval order statement
- Approval for a labeling update with the clinical study summary for the Attain Ability Straight Left Ventricular Lead.
Current openFDA PMA Record#
- Device
- Attain Ability Straight Left Ventricular Lead
- Applicant
- Medtronic, Inc.
- PMA number
- P080006
- Supplement
- S156
- Product code
- OJX
- Generic name
- Drug eluting permanent left ventricular (lv) pacemaker electrode
- Decision date
- 2021-02-09
- Decision code
- APPR
- Date received
- 2020-12-17
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- Approval for a labeling update with the clinical study summary for the Attain Ability Straight Left Ventricular Lead.