PMA P110033S020
- Device
- JUVEDERM VOLLURE XC
- Applicant
- Allergan
- PMA number
- P110033
- Supplement
- S020
- Product code
- LMH
- Decision date
- 2017-03-17
- Classification
- Implant, Dermal, For Aesthetic Use
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- Approval for injection into the mid to deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds) in adults over the age of 21.
- Summary
- <a href="http://www.accessdata.fda.gov/cdrh_docs/pdf11/P110033S020B.pdf" target="_new">Summary of Safety and Effectiveness</a>
Current openFDA PMA Record#
- Device
- JUVEDERM VOLLURE XC
- Applicant
- Allergan
- PMA number
- P110033
- Supplement
- S020
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2017-03-17
- Decision code
- APPR
- Date received
- 2015-09-30
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for injection into the mid to deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds) in adults over the age of 21.