PMA P010012S118
- Device
- EASYTRAK 2 LV-1 AND IS-1 LEADS
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S118
- Product code
- LWP
- Decision date
- 2006-06-23
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- APPROVAL FOR MODIFICATIONS TO THE INSTRUCTIONS FOR USE AND WARNINGS AS PART OF THE PHYSICIAN MANUALS.
Current openFDA PMA Record#
- Device
- EASYTRAK 2 LV-1 AND IS-1 LEADS
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S118
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2006-06-23
- Decision code
- APPR
- Date received
- 2006-03-09
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR MODIFICATIONS TO THE INSTRUCTIONS FOR USE AND WARNINGS AS PART OF THE PHYSICIAN MANUALS.