PMA P180036S038

Device: OPTIMIZER Smart System
Applicant: Impulse Dynamics (Usa), Inc.
PMA number: P180036
Supplement: S038
Product code: QFV
Decision date: 2025-07-15
Classification: Cardiovascular
Generic name: Implantable pulse generator
Approval order statement: approval for a manufacturing site located at Integer TJS, S. de R.L. de C.V., Calle 5 Norte No. 511 Ciudad Industrial, Tijuana, Baja California, MX 22444 for the manufacture of GUARDIO/VESTA charger devices

Current openFDA PMA Record#

Device: OPTIMIZER Smart System
Applicant: Impulse Dynamics (Usa), Inc.
PMA number: P180036
Supplement: S038
Product code: QFV
Generic name: Implantable pulse generator
Decision date: 2025-07-15
Decision code: APPR
Date received: 2025-02-19
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval for a manufacturing site located at Integer TJS, S. de R.L. de C.V., Calle 5 Norte No. 511 Ciudad Industrial, Tijuana, Baja California, MX 22444 for the manufacture of GUARDIO/VESTA charger devices