PMA P020012S009
- Device
- BELLAFILL
- Applicant
- Tiger Aesthetics Medical, LLC
- PMA number
- P020012
- Supplement
- S009
- Product code
- LMH
- Decision date
- 2014-12-23
- Classification
- Implant, Dermal, For Aesthetic Use
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- APPROVAL FOR THE BELLAFILL. THIS DEVICE IS INDICATED FOR THE CORRECTION OF NASOLABIAL FOLDS AND MODERATE TO SEVERE, ATROPHIC, DISTENSIBLE FACIAL ACNE SCARS ON THE CHEEK IN PATIENTS OVER THE AGE OF 21 YEARS.
- Summary
- <a href="http://www.accessdata.fda.gov/cdrh_docs/pdf2/P020012S009B.pdf" target="_new">Summary of Safety and Effectiveness</a>
Current openFDA PMA Record#
- Device
- BELLAFILL
- Applicant
- Tiger Aesthetics Medical, LLC
- PMA number
- P020012
- Supplement
- S009
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2014-12-23
- Decision code
- APPR
- Date received
- 2014-05-16
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR THE BELLAFILL. THIS DEVICE IS INDICATED FOR THE CORRECTION OF NASOLABIAL FOLDS AND MODERATE TO SEVERE, ATROPHIC, DISTENSIBLE FACIAL ACNE SCARS ON THE CHEEK IN PATIENTS OVER THE AGE OF 21 YEARS.