PMA P160042S009
- Device
- Revanesse Versa and Revanesse Versa+
- Applicant
- Prollenium Medical Technologies, Inc.
- PMA number
- P160042
- Supplement
- S009
- Product code
- LMH
- Decision date
- 2019-06-04
- Classification
- Implant, Dermal, For Aesthetic Use
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- Change to the Water For Injection System for Revanesse Versa and Revanesse Versa+.
Current openFDA PMA Record#
- Device
- Revanesse Versa and Revanesse Versa+
- Applicant
- Prollenium Medical Technologies, Inc.
- PMA number
- P160042
- Supplement
- S009
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2019-06-04
- Decision code
- OK30
- Date received
- 2019-05-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to the Water For Injection System for Revanesse Versa and Revanesse Versa+.