PMA P050046S019
- Device
- ACUITY STEERABLE LEAD FAMILY
- Applicant
- Guidant Corp.
- PMA number
- P050046
- Supplement
- S019
- Product code
- OJX
- Decision date
- 2012-12-20
- 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 ALTERNATE PRIMER MATERIAL.
Current openFDA PMA Record#
- Device
- ACUITY STEERABLE LEAD FAMILY
- Applicant
- Guidant Corp.
- PMA number
- P050046
- Supplement
- S019
- Product code
- OJX
- Generic name
- Drug eluting permanent left ventricular (lv) pacemaker electrode
- Decision date
- 2012-12-20
- Decision code
- APPR
- Date received
- 2012-11-14
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR AN ALTERNATE PRIMER MATERIAL.