FDA.reportPublic FDA data

Mainstay Medical (MML US, Inc.)

Matched from indexed company URL: MAINSTAY MEDICAL LIMITED

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30215202033021520203Mainstay Medical (MML US, Inc.)1N2026-01-012159 India Street San Diego CA US 92101

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
05391527770046ReActiv8 IPG - ReActiv8 Implantable Pulse Generator877-702-8488info@mainstay-medical.com
05391527770626ReActiv8 Magnet - ReActiv8 Magnet (for use in starting or stopping therapy dependent upon IPG programming).877-702-8488info@mainstay-medical.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3169562062035869P190021ReActiv8 Implantable Neurostimulation SystemQLK2020-06-16
3169561559393417

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
QLK 12020-06-16

PMA#

GUDID#