FDA.reportPublic FDA data

ReShape Lifesciences, LLC.

Matched from indexed company URL: ReShape Lifesciences

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30050256973005025697ReShape Lifesciences, LLC.1N2020-04-252800 Patton Rd Suite B Saint Paul MN US 55113
30135086473013508647ReShape Lifesciences1N2020-04-251001 Calle Amanecer San Clemente CA US 92673

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
00850007764173LAP-BAND® System Calibration Tube - B-2017844-937-7374CustomerService@ReShapelifesci.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1402041933851935P130019MAESTRO RECHARGEABLE SYSTEMPIM2015-01-14
2067451250505105P000008LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEMLTI2001-06-05
2067451301257265K002838GASTRIC SUCTION AND DRAINAGE CATHETERKNT2001-07-09

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
PIM12015-01-14
KNT12001-07-09
LTI12001-06-05

PMA#

Obalon Balloon System

2022-07-18

ReShape Lifesciences, Inc.1001 Calle Amanecersan Clemente, CA 92673 PMA NumberP160001 Supplement NumberS047 Date Received01/19/2022 Decision Date07/18/2022 Product Code LTI  Advisory Committee Gastroenterology/Urology Supplement Typenormal 180 Day Track No ...

64 records. Showing 1-40. Next

PMN#

GUDID#

Model 2200A-47E Maestro Anterior Lead - The Model 2200A-47E Anterior Lead is provided sterile for implantation. It is a flexible lead that contains bipolar platinum/iridium tip and ring electrodes with an insulated lead body. Electrical current is delivered to the tip electrode which is implanted to be in contact with the anterior trunk of the vagus nerve to block nerve signals. The ring electrode is placed in contact with the stomach to measure lead impedance. Sutures are used to anchor and stabilize the lead placement. The lead is connected to the implanted Rechargeable Neuroregulator.

Reshape Lifesciences Inc.

2015-04-17

Model 2200P-47E Maestro Posterior Lead - The Model 2200P-47E Posterior Lead is provided sterile for implantation. It is a flexible lead that contains bipolar platinum/iridium tip and ring electrodes with an insulated lead body. Electrical current is delivered to the tip electrode which is implanted to be in contact with the posterior trunk of the vagus nerve to block nerve signals. The ring electrode is placed in contact with the stomach to measure lead impedance. Sutures are used to anchor and stabilize the lead placement. The lead is connected to the implanted Rechargeable Neuroregulator. The Posterior Lead contains a white stripe along the lead body, a white suture tab, and a white coating on its' conductor cables to distinguish it from the Anterior Lead.

Reshape Lifesciences Inc.

2015-04-17

Model 2402 Maestro Mobile Charger - The Model 2402 Mobile Charger (MC) is a non-sterile external component that is powered by a rechargeable, lithium-ion battery. The MC charges the Rechargeable Neuroregulator (RNR) when connected to a Transmit Coil positioned over the RNR. The MC also provides communication between the Clinician Programmer and RNR to allow up and down loading of data, display battery charge levels, indicate proper positioning of the Transmit Coil, alert patient to fault conditions, and allow for inactivation of therapy and turning off the RNR if needed.

Reshape Lifesciences Inc.

2015-04-17

Model 2502 Maestro Clinician Programmer - The Model 2502 Clinician Programmer (CP) is a non-sterile external component that consists of a commercially available laptop computer configured with customized software. The CP connects to the Mobile Charger with a custom Programmer Cable. The CP enables the clinician to enter and modify therapy parameters and therapy schedule in the Rechargeable Neuroregulator. The graphical user interface of the CP allows the clinician to monitor system performance and patient compliance. The CP also provides access to the Instructions for Use manuals.

Reshape Lifesciences Inc.

2015-04-17