FDA.reportPublic FDA data

PMA P150012S095

Device
Imageready MR Conditional Pacing System and Ingevity Pace/Sense Lead
Applicant
Boston Scientific
PMA number
P150012
Supplement
S095
Product code
LWP
Decision date
2020-06-19
Generic name
Implantable pulse generator, pacemaker (non-CRT)
Approval order statement
Approval of the revised protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P150012/S083.

Current openFDA PMA Record#

Device
Imageready MR Conditional Pacing System and Ingevity Pace/Sense Lead
Applicant
Boston Scientific
PMA number
P150012
Supplement
S095
Product code
LWP
Generic name
Implantable pulse generator, pacemaker (non-CRT)
Decision date
2020-06-19
Decision code
APPR
Date received
2020-05-22
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Postapproval Study Protocol
Approval order statement
Approval of the revised protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P150012/S083.