FDA.reportPublic FDA data

PMA P110042S143

Device
EMBLEM S-ICD Pulse Generator and EMBLEM MRI S-ICD Pulse Generator
Applicant
Boston Scientific Corporation
Product code
LWS
Decision date
2020-10-16
Generic name
Implantable cardioverter defibrillator (non-CRT)
Approval order statement
Approval to allow an additional mold release/de-nest agent to be applied to the polyethylene terephthalate glycol (PETG) sheets used to form sterile packaging.

Current openFDA PMA Record#

Device
EMBLEM S-ICD Pulse Generator and EMBLEM MRI S-ICD Pulse Generator
Applicant
Boston Scientific Corporation
PMA number
P110042
Supplement
S143
Product code
LWS
Generic name
Implantable cardioverter defibrillator (non-CRT)
Decision date
2020-10-16
Decision code
APPR
Date received
2020-08-13
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval to allow an additional mold release/de-nest agent to be applied to the polyethylene terephthalate glycol (PETG) sheets used to form sterile packaging.