FDA.reportPublic FDA data

PMA P910077S199

Device
DF-1 Plug (Model 6996)
Applicant
Boston Scientific
PMA number
P910077
Supplement
S199
Product code
LWS
Decision date
2026-05-15
Classification
Cardiovascular
Generic name
Implantable cardioverter defibrillator (non-CRT)
Approval order statement
to change sites for ethylene oxide (EO) gas sterilization operations and final packaging activities for the Accessories used with the Cardiac Rhythm Management (CRM) division’s Pulse Generators and Leads.

Current openFDA PMA Record#

Device
DF-1 Plug (Model 6996)
Applicant
Boston Scientific
PMA number
P910077
Supplement
S199
Product code
LWS
Generic name
Implantable cardioverter defibrillator (non-CRT)
Decision date
2026-05-15
Decision code
OK30
Date received
2026-04-17
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
to change sites for ethylene oxide (EO) gas sterilization operations and final packaging activities for the Accessories used with the Cardiac Rhythm Management (CRM) division’s Pulse Generators and Leads.