PMA P160042S004
- Device
- Revanesse Versa, Revanesse Versa +
- Applicant
- Prollenium Medical Technologies, Inc.
- PMA number
- P160042
- Supplement
- S004
- Product code
- LMH
- Decision date
- 2019-03-15
- Classification
- Implant, Dermal, For Aesthetic Use
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- Approval for the increase in syringe volume from 1.0 mL to 1.2 mL of Revanesse Versa and Revanesse Versa+.
Current openFDA PMA Record#
- Device
- Revanesse Versa, Revanesse Versa +
- Applicant
- Prollenium Medical Technologies, Inc.
- PMA number
- P160042
- Supplement
- S004
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2019-03-15
- Decision code
- APPR
- Date received
- 2018-05-29
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the increase in syringe volume from 1.0 mL to 1.2 mL of Revanesse Versa and Revanesse Versa+.