Data / Medical devices / Canada / Prollenium Medical Technologies Inc.
Prollenium Medical Technologies Inc.: FDA-registered device maker in Richmond Hill Ontario, Canada, 1 PMA approval
Prollenium Medical Technologies Inc. is registered with the FDA (registration 3019585045) in Richmond Hill Ontario, Canada. It lists 3 device types. The FDA files 1 PMA approval under its listings, the newest dated August 4, 2017. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3019585045
- Address
- 29 East Wilmot Street, Richmond Hill Ontario, Canada, L4B1A3
- Owner or operator
- Prollenium Medical Technologies Inc. (10055618)
- Roles
- Complaint file establishment, Exporter to the US, Foreign private label distributor, Manufacturer
- First device listed
- August 23, 2017
- Registered through
- 2026
- Brand names listed
- Revanesse Gel Pack, Revanesse Versa, Revanesse Versa+ with Lidocaine, Revanesse Versa+ with Lidocaine 1.2 mL, Revanesse® Lips + with Lidocaine, Revanesse® Lips + with Lidocaine 1.2 mL, Revanesse® Versa 1.2 mL, SoftFil® EasyGuide and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cannula, Surgical, General & Plastic Surgery | GEA | 1 | Complaint file establishment, Exporter to the US, Foreign private label distributor | accessdata.fda.gov |
| Implant, Dermal, For Aesthetic Use | LMH | 3 | Manufacturer | accessdata.fda.gov |
| Pack, Hot Or Cold, Reusable | IME | 1 | Complaint file establishment, Exporter to the US, Foreign private label distributor | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| August 4, 2017 | P160042 | REVANESSE ULTRA | LMH | 24 | October 14, 2026 | accessdata.fda.gov |
Compare with other makers
- All makers of Cannula, Surgical, General & Plastic Surgery
- All makers of Implant, Dermal, For Aesthetic Use
- All makers of Pack, Hot Or Cold, Reusable
Updated October 14, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.