PMA P160042S010
- Device
- Revanesse® Lips+
- Applicant
- Prollenium Medical Technologies, Inc.
- Product code
- LMH
- Decision date
- 2020-09-21
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- Approval for the Revanesse® Lips+. The device is indicated for submucosal implantation for lip augmentation in patients 22 years of age or older.
Current openFDA PMA Record#
- Device
- Revanesse® Lips+
- Applicant
- Prollenium Medical Technologies, Inc.
- PMA number
- P160042
- Supplement
- S010
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2020-09-21
- Decision code
- APPR
- Date received
- 2019-09-30
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for the Revanesse® Lips+. The device is indicated for submucosal implantation for lip augmentation in patients 22 years of age or older.