PMA P160042S003
- Device
- Revanesse Versa +
- Applicant
- Prollenium Medical Technologies, Inc.
- PMA number
- P160042
- Supplement
- S003
- Product code
- LMH
- Decision date
- 2018-08-02
- Classification
- Implant, Dermal, For Aesthetic Use
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- Approval for the addition of lidocaine to the formulation of Revanesse Versa.
Current openFDA PMA Record#
- Device
- Revanesse Versa +
- Applicant
- Prollenium Medical Technologies, Inc.
- PMA number
- P160042
- Supplement
- S003
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2018-08-02
- Decision code
- APPR
- Date received
- 2017-12-20
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the addition of lidocaine to the formulation of Revanesse Versa.