PMA P010012S279
- Device
- EASYTRAK 2 LV-1 & IS-1, EASYTRAK 3 LV-1 & IS-1, AND ACUITY SPIRAL LEADS
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S279
- Product code
- LWP
- Decision date
- 2012-02-29
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- CHANGE TO THE BACTERIAL ENDOTOXIN SAMPLING PLAN.
Current openFDA PMA Record#
- Device
- EASYTRAK 2 LV-1 & IS-1, EASYTRAK 3 LV-1 & IS-1, AND ACUITY SPIRAL LEADS
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S279
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2012-02-29
- Decision code
- OK30
- Date received
- 2012-01-24
- Supplement type
- 30-Day Notice
- Approval order statement
- CHANGE TO THE BACTERIAL ENDOTOXIN SAMPLING PLAN.