PMA P030050S002
- Device
- SCULPTRA AESTHETIC
- Applicant
- Q-Med AB
- PMA number
- P030050
- Supplement
- S002
- Product code
- LMH
- Decision date
- 2009-07-28
- Classification
- Implant, Dermal, For Aesthetic Use
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- APPROVAL FOR SCULPTRA AESTHETIC. THE DEVICE IS INDICATED FOR USE IN IMMUNE-COMPETENT PEOPLE AS A SINGLEREGIMEN FOR CORRECTION OF SHALLOW TO DEEP NASOLABIAL FOLD CONTOUR DEFICIENCIES AND OTHER FACIALWRINKLES IN WHICH DEEP DERMAL GRID PATTERN (CROSS-HATCH) INJECTION TECHNIQUE IS APPROPRIATE.
- Summary
- <a href="http://www.accessdata.fda.gov/cdrh_docs/pdf3/P030050S002B.pdf" target="_new">Summary of Safety and Effectiveness</a>
Current openFDA PMA Record#
- Device
- SCULPTRA AESTHETIC
- Applicant
- Q-Med AB
- PMA number
- P030050
- Supplement
- S002
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2009-07-28
- Decision code
- APPR
- Date received
- 2006-07-28
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR SCULPTRA AESTHETIC. THE DEVICE IS INDICATED FOR USE IN IMMUNE-COMPETENT PEOPLE AS A SINGLEREGIMEN FOR CORRECTION OF SHALLOW TO DEEP NASOLABIAL FOLD CONTOUR DEFICIENCIES AND OTHER FACIALWRINKLES IN WHICH DEEP DERMAL GRID PATTERN (CROSS-HATCH) INJECTION TECHNIQUE IS APPROPRIATE.