PMA P010012S380
- Device
- EASYTRAK 2+ IS-1 CORONARY VENOUS STEROID ELUTING DUAL ELECTRODE PACE/SENSE LEADS
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S380
- Product code
- LWP
- Decision date
- 2015-01-21
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- APPROVAL FOR AN ADDITION OF SILGLIDE COATING TO THE OUTER DISTAL SILICONE BODY TUBING TO EASE DELIVERY THROUGH AN INNER CATHETER 7 FRENCH AND ASSOCIATED LABEL CHANGES TO REBRAND THE LEAD AS EASYTRAK 2+.
Current openFDA PMA Record#
- Device
- EASYTRAK 2+ IS-1 CORONARY VENOUS STEROID ELUTING DUAL ELECTRODE PACE/SENSE LEADS
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S380
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2015-01-21
- Decision code
- APPR
- Date received
- 2014-11-28
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR AN ADDITION OF SILGLIDE COATING TO THE OUTER DISTAL SILICONE BODY TUBING TO EASE DELIVERY THROUGH AN INNER CATHETER 7 FRENCH AND ASSOCIATED LABEL CHANGES TO REBRAND THE LEAD AS EASYTRAK 2+.