PMA P010012S315
- Device
- ACUITY SPIRAL AND EASYTRAK 3 IS-1 LEADS
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S315
- 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 SPIRAL AND EASYTRAK 3 IS-1 LEADS
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S315
- 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.