RESHAPE INTEGRATED DUAL BALLOON SYSTEM, RESHAPE BALLOON ASSEMBLY, RESHAPE REMOVAL CATHETER, RESHAPE VALVE SEALANT

Implant, Intragastric For Morbid Obesity

FDA Premarket Approval P140012 S003

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Approval for a dimensional change to the torque transmission wire component of the reshape removal catheter assembly.

DeviceRESHAPE INTEGRATED DUAL BALLOON SYSTEM, RESHAPE BALLOON ASSEMBLY, RESHAPE REMOVAL CATHETER, RESHAPE VALVE SEALANT
Classification NameImplant, Intragastric For Morbid Obesity
Generic NameImplant, Intragastric For Morbid Obesity
ApplicantAppollo Endosurgery
Date Received2015-11-18
Decision Date2016-01-22
PMAP140012
SupplementS003
Product CodeLTI
Advisory CommitteeGastroenterology/Urology
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address Appollo Endosurgery 1120 S Capital Of Tx Hwy bldg 1, Ste 300 austin, TX 78746

Supplemental Filings

Supplement NumberDateSupplement Type
P140012Original Filing
S013 2018-05-02 Special (immediate Track)
S012 2018-02-26 Normal 180 Day Track No User Fee
S011 2017-09-27 30-day Notice
S010 2017-04-28 Normal 180 Day Track No User Fee
S009 2017-03-22 Special (immediate Track)
S008 2017-01-23 30-day Notice
S007 2016-12-19 30-day Notice
S006 2016-12-07 30-day Notice
S005 2016-09-26 30-day Notice
S004 2015-12-01 30-day Notice
S003 2015-11-18 Real-time Process
S002 2015-09-28 Normal 180 Day Track
S001 2015-08-26 Normal 180 Day Track No User Fee

NIH GUDID Devices

Device IDPMASupp
B001RSM9001 P140012 000
B001RSM2101 P140012 000
B001RSM1011 P140012 000
B001RSM1101 P140012 002

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