Product code LNM
- Device name
- Agent, Bulking, Injectable For Gastro-Urology Use
- Medical specialty
- Unknown
- Device class
- 3
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P040047S082 | COAPTITE® AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE | Merz North America, Inc. | 2026-05-14 |
| P040047S081 | COAPTITE® Injectable Implant | Merz North America, Inc. | 2026-03-18 |
| P980053S021 | Durasphere Injectable Bulking Agent | Carbon Medical Technologies, Inc. | 2026-03-13 |
| P040047S080 | COAPTITE | Merz North America, Inc. | 2026-01-13 |
| P170023S023 | Bulkamid Urethral Bulking System | Boston Scientific Corporation | 2026-01-02 |
| P040047S079 | COAPTITE | Merz North America, Inc. | 2025-12-12 |
| P040047S078 | COAPTITE Injectable Implant | Merz North America, Inc. | 2025-08-27 |
| P040047S077 | COAPTITE® | Merz North America, Inc. | 2025-06-16 |
| P170023S021 | Bulkamid Urethral Bulking System | Boston Scientific Corporation | 2025-05-22 |
| P170023S022 | Bulkamid Urethral Bulking System | Boston Scientific Corporation | 2025-05-20 |
| P040047S076 | Coaptite | Merz North America, Inc. | 2025-04-01 |
| P170023S020 | Bulkamid Urethral Bulking System | Boston Scientific Corporation | 2025-03-05 |
| P170023S019 | Bulkamid Urethral Bulking System | Boston Scientific Corporation | 2024-11-19 |
| P170023S018 | Bulkamid Urethral Bulking System | Boston Scientific Corporation | 2024-09-03 |
| P170023S017 | Bulkamid Urethral Bulking System | Boston Scientific Corporation | 2024-07-30 |
| P040047S075 | COAPTITE Injectable Implant | Merz North America, Inc. | 2024-07-10 |
| P000029S098 | Deflux® Injectable Gel | Palette Life Sciences | 2024-05-31 |
| P040047S074 | Coaptite Injectable Implant | Merz North America, Inc. | 2024-05-10 |
| P040047S070 | Coaptite Injectable Implant | Merz North America, Inc. | 2024-01-25 |
| P980053S020 | Durasphere® Injectable Bulking Agent | Carbon Medical Technologies, Inc. | 2024-01-18 |
| P170023S016 | Bulkamid Urethral Bulking System | Boston Scientific Corporation | 2023-12-18 |
| P100014S035 | Solesta® Injectable Gel | Palette Life Sciences | 2023-12-07 |
| P000029S097 | Deflux® Injectable Gel | Palette Life Sciences | 2023-12-07 |
| P040047S073 | COAPTITE Injectable Implant | Merz North America, Inc. | 2023-10-12 |
| P040047S072 | Coaptite Injectable Implant | Merz North America, Inc. | 2023-09-20 |
| P040047S071 | COAPTITE Injectable Implant | Merz North America, Inc. | 2023-09-13 |
| P170023S015 | Bulkamid Urethral Bulking System | Boston Scientific Corporation | 2023-07-12 |
| P100014S034 | Solesta Injectable Gel | Palette Life Sciences | 2023-07-11 |
| P000029S096 | Deflux Injectable Gel | Palette Life Sciences | 2023-07-11 |
| P040050S013 | Macroplastique Implants | Uroplasty, LLC | 2023-05-09 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10810235030645 | Coaptite | MERZ NORTH AMERICA, INC. | 2024-10-15 |
| 10810005340509 | Bulkamid | AXONICS MODULATION TECHNOLOGIES, INC. | 2023-09-12 |
| 10810005340493 | Bulkamid | AXONICS MODULATION TECHNOLOGIES, INC. | 2023-08-30 |
| 05704101500500 | Bulkamid | Contura International A/S | 2020-03-10 |
| 00850004725023 | Deflux Metal Needle | PALETTE LIFE SCIENCES, INC. | 2019-02-11 |
| 00850004725009 | Deflux | PALETTE LIFE SCIENCES, INC. | 2019-02-01 |
| 00850004725016 | Solesta | PALETTE LIFE SCIENCES, INC. | 2019-02-01 |
| 00365649850035 | Solesta® | SALIX PHARMACEUTICALS, LTD. | 2014-10-31 |
| 00365649922039 | Deflux® | SALIX PHARMACEUTICALS, LTD. | 2014-10-31 |
| 08714729804796 | Coaptite | MERZ NORTH AMERICA, INC. | 2014-09-17 |
| 00858015005004 | Durasphere ® EXP | Carbon Medical Technologies, Inc. | 2014-09-17 |
| 00858015005011 | Durasphere ® EXP | Carbon Medical Technologies, Inc. | 2014-09-17 |
| 08717591240266 | Macroplastique Implants | Uroplasty, Inc. | 2014-06-20 |