Approval for labeling changes to post-market surveillance information of revanesse versa, revanesse versa+, and revanesse lips+.
| Device | Revanesse Versa, Revanesse Versa+, Revanesse Lips+ |
| Generic Name | Implant, Dermal, For Aesthetic Use |
| Applicant | PROLLENIUM MEDICAL TECHNOLOGIES INC. |
| Date Received | 2021-03-17 |
| Decision Date | 2021-04-16 |
| PMA | P160042 |
| Supplement | S015 |
| Product Code | LMH |
| Advisory Committee | General & Plastic Surgery |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | PROLLENIUM MEDICAL TECHNOLOGIES INC. 138 Industrial Parkway North aurora L4G 4 |
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