Approval for 1) a new delivery catheter gen1; 2) product packaging for the reshape integrated dual balloon system; 3) extension of the balloon and delivery catheter assembly to 24 months; and 4) a new supplier for the delivery catheter assembly (medbio, inc. , in grand rapids, michigan).
| Device | RESHAPE INTEGRATED DUAL BALLOON SYSTEM,RESHAPE BALLOON ASSEMBLY,RESHAPE REMOVAL CATHETER,RESHAPE VALVE SEALANT |
| Classification Name | Implant, Intragastric For Morbid Obesity |
| Generic Name | Implant, Intragastric For Morbid Obesity |
| Applicant | Appollo Endosurgery |
| Date Received | 2015-09-28 |
| Decision Date | 2015-12-21 |
| PMA | P140012 |
| Supplement | S002 |
| Product Code | LTI |
| Advisory Committee | Gastroenterology/Urology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Appollo Endosurgery 1120 S Capital Of Tx Hwy bldg 1, Ste 300 austin, TX 78746 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P140012 | | Original 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