PMA P910077S167

Device: Programmer Recorder Monitor (PRM) for Implantable Pulse Generators, Model 3300 LATITUDE Programming System, Model 6395 I
Applicant: Boston Scientific
PMA number: P910077
Supplement: S167
Product code: LWS
Decision date: 2019-01-09
Classification: Implantable Cardioverter Defibrillator (non-crt)
Generic name: Implantable cardioverter defibrillator (non-CRT)
Approval order statement: Approval of a manufacturing site duplication for the Model 3300 Programmer, Model 6395 Telemetry Wand, and accessories packaging/labeling.

Current openFDA PMA Record#

Device: Programmer Recorder Monitor (PRM) for Implantable Pulse Generators, Model 3300 LATITUDE Programming System, Model 6395 I
Applicant: Boston Scientific
PMA number: P910077
Supplement: S167
Product code: LWS
Generic name: Implantable cardioverter defibrillator (non-CRT)
Decision date: 2019-01-09
Decision code: APPR
Date received: 2018-07-18
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval of a manufacturing site duplication for the Model 3300 Programmer, Model 6395 Telemetry Wand, and accessories packaging/labeling.