PMA P150012S021
- Device
- ESSENTIO, PROPONENT, ACCOLADE, INGEVITY MRI'S & SLIT SUTURE SLEEVE ACCESSORY (FOR INGEVITY MRI LEADS)
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S021
- Product code
- LWP
- Decision date
- 2017-04-11
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- Approval for the addition of 3T MR Conditional labeling for the Image Ready MR Conditional Pacing System consisting of an Accolade MRI pacemaker with one or two INGEVITY MRI leads. Approval to expand the Image Ready System to include 1.5T MR Conditional labeling for the FINELINE II Sterox and Sterox EZ leads.
Current openFDA PMA Record#
- Device
- ESSENTIO, PROPONENT, ACCOLADE, INGEVITY MRI'S & SLIT SUTURE SLEEVE ACCESSORY (FOR INGEVITY MRI LEADS)
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S021
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2017-04-11
- Decision code
- APPR
- Date received
- 2016-12-09
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the addition of 3T MR Conditional labeling for the Image Ready MR Conditional Pacing System consisting of an Accolade MRI pacemaker with one or two INGEVITY MRI leads. Approval to expand the Image Ready System to include 1.5T MR Conditional labeling for the FINELINE II Sterox and Sterox EZ leads.