PMA P050046S023
- Device
- ACUITY STEERABLE
- Applicant
- Guidant Corp.
- PMA number
- P050046
- Supplement
- S023
- Product code
- OJX
- Decision date
- 2014-04-24
- Classification
- Drug Eluting Permanent Left Ventricular (lv) Pacemaker Electrode
- Generic name
- Drug eluting permanent left ventricular (lv) pacemaker electrode
- Approval order statement
- APPROVAL FOR A NEW OUTER SALES BOX AND CLOSURE LABELS FOR THE LEADS.
Current openFDA PMA Record#
- Device
- ACUITY STEERABLE
- Applicant
- Guidant Corp.
- PMA number
- P050046
- Supplement
- S023
- Product code
- OJX
- Generic name
- Drug eluting permanent left ventricular (lv) pacemaker electrode
- Decision date
- 2014-04-24
- Decision code
- APPR
- Date received
- 2014-01-28
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A NEW OUTER SALES BOX AND CLOSURE LABELS FOR THE LEADS.