PMA P160042S001
- Device
- Revanesse Ultra (Revanesse Versa)
- Applicant
- Prollenium Medical Technologies, Inc.
- PMA number
- P160042
- Supplement
- S001
- Product code
- LMH
- Decision date
- 2017-10-02
- Classification
- Implant, Dermal, For Aesthetic Use
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- Approval for a name change from Revanesse Ultra to Revanesse Versa.
Current openFDA PMA Record#
- Device
- Revanesse Ultra (Revanesse Versa)
- Applicant
- Prollenium Medical Technologies, Inc.
- PMA number
- P160042
- Supplement
- S001
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2017-10-02
- Decision code
- APPR
- Date received
- 2017-08-14
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for a name change from Revanesse Ultra to Revanesse Versa.