Data / Medical devices / Canada / Prollenium Medical Technologies Inc.
Prollenium Medical Technologies Inc.: FDA-registered device maker in Aurora Ontario, Canada, 1 PMA approval
Prollenium Medical Technologies Inc. is registered with the FDA (registration 3004423487) in Aurora Ontario, Canada. It lists 3 device types. The FDA files 1 PMA approval under its listings, the newest dated August 4, 2017. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3004423487
- Address
- 138 Industrial Pkwy N., Aurora Ontario, Canada, L4G4C3
- Owner or operator
- Prollenium Medical Technologies Inc. (10055618)
- Roles
- Complaint file establishment, Exporter to the US, Foreign private label distributor, Manufacturer, Specification developer
- 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, Specification developer | accessdata.fda.gov |
| Implant, Dermal, For Aesthetic Use | LMH | 3 | Complaint file establishment, 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 |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| November 15, 2018 | 83834 | Class II | Terminated | Revanesse Versa, PN40081 | Labeling error. The product is labeled with an 18 month expiration date, however the product is approved for 12 months. | accessdata.fda.gov |
Compare with other makers
- All makers of Cannula, Surgical, General & Plastic Surgery
- All makers of Pack, Hot Or Cold, Reusable
- All makers of Implant, Dermal, For Aesthetic Use
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.