PMA P160042S012
- Device
- Revanesse Versa+
- Applicant
- Prollenium Medical Technologies, Inc.
- PMA number
- P160042
- Supplement
- S012
- Product code
- LMH
- Decision date
- 2020-10-13
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- Approval to change the shelf-life from 18 months to 24 months for Revanesse Versa+
Current openFDA PMA Record#
- Device
- Revanesse Versa+
- Applicant
- Prollenium Medical Technologies, Inc.
- PMA number
- P160042
- Supplement
- S012
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2020-10-13
- Decision code
- APPR
- Date received
- 2020-07-15
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval to change the shelf-life from 18 months to 24 months for Revanesse Versa+