PMA P110033S018
- Device
- JUVEDERM VOLBELLA XC
- Applicant
- Allergan
- PMA number
- P110033
- Supplement
- S018
- Product code
- LMH
- Decision date
- 2016-05-31
- Classification
- Implant, Dermal, For Aesthetic Use
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- Approval for JUVÉDERM VOLBELLA® XC injectable gel. The device is indicated for injection into the lips for lip augmentation and for correction of perioral rhytids in adults over the age of 21.
- Summary
- <a href="http://www.accessdata.fda.gov/cdrh_docs/pdf11/P110033S018B.pdf" target="_new">Summary of Safety and Effectiveness</a>
Current openFDA PMA Record#
- Device
- JUVEDERM VOLBELLA XC
- Applicant
- Allergan
- PMA number
- P110033
- Supplement
- S018
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2016-05-31
- Decision code
- APPR
- Date received
- 2015-08-03
- Supplement type
- Panel Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for JUVÉDERM VOLBELLA® XC injectable gel. The device is indicated for injection into the lips for lip augmentation and for correction of perioral rhytids in adults over the age of 21.