PMA P160042S011
- Device
- Revanesse Versa+
- Applicant
- Prollenium Medical Technologies, Inc.
- PMA number
- P160042
- Supplement
- S011
- Product code
- LMH
- Decision date
- 2020-04-21
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- Approval of change of shelf-life from 12 months to 18 months for Revanesse Versa+.
Current openFDA PMA Record#
- Device
- Revanesse Versa+
- Applicant
- Prollenium Medical Technologies, Inc.
- PMA number
- P160042
- Supplement
- S011
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2020-04-21
- Decision code
- APPR
- Date received
- 2020-01-22
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval of change of shelf-life from 12 months to 18 months for Revanesse Versa+.