LNM · Agent, Bulking, Injectable For Gastro-Urology Use
· Class 3
Overview
| Product Code | LNM |
|---|---|
| Device Name | Agent, Bulking, Injectable For Gastro-Urology Use |
| Device Class | Class 3 |
| Review Panel |
Recent Cleared Devices (9 of 9)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P170023 | Bulkamid Urethral Bulking System | Boston Scientific Corporation | Jan 28, 2020 | APPR |
| P100014 | SOLESTA INJECTABLE GEL | Palette Life Sciences | May 27, 2011 | APPR |
| P040050 | MACROPLASTIQUE IMPLANTS | Uroplasty, LLC | Oct 30, 2006 | APPR |
| P040047 | COAPTITE | Merz North America, Inc. | Nov 10, 2005 | APPR |
| P030030 | URYX URETHRAL BULKING AGENT | C.R. Bard, Inc. | Dec 16, 2004 | APWD |
| P020006 | ENTERYX PROCEDURE KIT | Boston Scientific Corp | Apr 22, 2003 | APWD |
| P000029 | DEFLUX INJECTABLE GEL | Palette Life Sciences | Sep 24, 2001 | APPR |
| P980053 | DURASPHERE INJECTABLE BULKING AGENT | Carbon Medical Technologies, Inc. | Sep 13, 1999 | APPR |
| P900030 | CONTIGEN (TM) BARD (R) COLLAGEN IMPLANT | Allergan, Inc. | Sep 30, 1993 | APWD |
Top Applicants
- Palette Life Sciences — 2 clearances
- Allergan, Inc. — 1 clearance
- Boston Scientific Corp — 1 clearance
- Boston Scientific Corporation — 1 clearance
- C.R. Bard, Inc. — 1 clearance
