This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
| Device | Revanesse Versa+ with Lidocaine (1.0 mL and 1.2 mL) and Revanesse Lips+ with Lidocaine (1.0 mL and 1.2 mL) |
| Generic Name | Implant, Dermal, For Aesthetic Use |
| Applicant | PROLLENIUM MEDICAL TECHNOLOGIES INC.138 Industrial Parkway Northaurora L4G 4 PMA NumberP160042 Supplement NumberS017 Date Received10/05/2021 Decision Date04/20/2022 Product Code LMH Advisory Committee General & Plastic Surgery Supplement Type135 Review Track For 30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2021-10-05 |
| Decision Date | 2022-04-20 |
| PMA | P160042 |
| Supplement | S017 |
| Product Code | LMH |
| Advisory Committee | General & Plastic Surgery |
| Supplement Type | 135 Review Track For 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | PROLLENIUM MEDICAL TECHNOLOGIES INC. 138 Industrial Parkway North aurora L4G 4 PMA NumberP160042 Supplement NumberS017 Date Received10/05/2021 Decision Date04/20/2022 Product Code LMH Advisory Committee General & Plastic Surgery Supplement Type135 Review Track For 30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductYes Approval Order Statement Approval For A Change To The Sample Preparation In The Lidocaine HCl Assay |
| 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 66980800001000 | P160042 | 000 |
| 66980800001017 | P160042 | 003 |
| 66980800001024 | P160042 | 004 |
| 10669808003032 | P160042 | 014 |