PMA P010012S268
- Device
- EASYTRAK 2 IS-1 LEAD
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S268
- Product code
- LWP
- Decision date
- 2011-08-05
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- APPROVAL FOR CHANGES TO THE POLYURETHANE TUBING SPECIFICATIONS AND THE ADDITION OF AN ALTERNATE POLYURETHANE TUBING SUPPLIER.
Current openFDA PMA Record#
- Device
- EASYTRAK 2 IS-1 LEAD
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S268
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2011-08-05
- Decision code
- APPR
- Date received
- 2011-06-06
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR CHANGES TO THE POLYURETHANE TUBING SPECIFICATIONS AND THE ADDITION OF AN ALTERNATE POLYURETHANE TUBING SUPPLIER.