Approval for the revanesse ultra. The device is indicated for injection into the mid to deep dermis for correction of moderate to severe facial wrinkles and folds, such as nasolabial folds, in adults 22 years of age or more.
| Device | REVANESSE ULTRA |
| Classification Name | Implant, Dermal, For Aesthetic Use |
| Generic Name | Implant, Dermal, For Aesthetic Use |
| Applicant | PROLLENIUM MEDICAL TECHNOLOGIES INC. |
| Date Received | 2016-09-22 |
| Decision Date | 2017-08-04 |
| Notice Date | 2017-08-07 |
| PMA | P160042 |
| Supplement | S |
| Product Code | LMH |
| Docket Number | 17M-4711 |
| Advisory Committee | General & Plastic Surgery |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | PROLLENIUM MEDICAL TECHNOLOGIES INC. 138 Industrial Parkway North aurora L4G 4 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| Approval Order: | Approval Order |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P160042 | | Original Filing |
| S017 |
2021-10-05 |
135 Review Track For 30-day Notice |
| S016 | | |
| S015 |
2021-03-17 |
Special (immediate Track) |
| S014 | | |
| S013 | | |
| S012 |
2020-07-15 |
Real-time Process |
| S011 |
2020-01-22 |
Real-time Process |
| S010 | | |
| S009 |
2019-05-06 |
30-day Notice |
| S008 | | |
| S007 | | |
| S006 | | |
| S005 | | |
| S004 |
2018-05-29 |
Normal 180 Day Track |
| S003 |
2017-12-20 |
Normal 180 Day Track |
| S002 | | |
| S001 |
2017-08-14 |
Normal 180 Day Track No User Fee |
NIH GUDID Devices