Revanesse Versa+
by Prollenium Medical Technologies Inc.
PMA P160042
Active
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP160042 | Date4 Aug 2017 | StatusActive |
Recalls
-
- Terminated Z-1146-2020
Labeling error. The product is labeled with an 18 month expiration date, however the product is approved for 12 months.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Trade Name
- Revanesse Ultra
- Generic Name
- Implant, dermal, for aesthetic use
- FDA applicant
- Prollenium Medical Technologies, Inc.
- PMA Number
- FDA Product Code
- LMH
- Device Class
- Class III
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- APPR Approved
Overview
AI-generated summary, 18 Sep 2026
Revanesse Versa+ is an implant, dermal, for aesthetic use, 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. It is manufactured by Prollenium Medical Technologies Inc. and received FDA PMA approval on August 4, 2017.
The device is supplied as a sterile, single-use implant for use in clinical settings such as general and plastic surgery practices. It is not MRI conditional unless explicitly stated, and storage and handling should follow manufacturer guidelines. Authorization is under FDA PMA number P160042, with product code LMH.
Other devices from Prollenium Medical Technologies Inc.
Questions
AI-generated answers, 18 Sep 2026
What is Revanesse Versa+ used for?
Revanesse Versa+ is indicated for injection into the mid to deep dermis for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds, in adults 22 years of age or older, based on the device's approval documentation.
Who manufactures Revanesse Versa+ and what regulatory pathway was used?
Revanesse Versa+ is manufactured by Prollenium Medical Technologies Inc. and received approval through the FDA Premarket Approval (PMA) pathway, with PMA number P160042 granted on August 4, 2017.
Is Revanesse Versa+ reusable or single-use?
Revanesse Versa+ is supplied as a sterile, single-use implant, as implied by its classification as a dermal implant for aesthetic use and standard clinical supply practices for such devices, though reuse is not mentioned in the provided data.