PMA P040024S099
- Device
- Restylane Lyft with Lidocaine
- Applicant
- Q-Med AB
- PMA number
- P040024
- Supplement
- S099
- Product code
- PKY
- Decision date
- 2018-05-18
- Classification
- Implant, Dermal, For Aesthetic Use In The Hands
- Generic name
- Implant, dermal, for aesthetic use in the hands
- Approval order statement
- Approval for the Restylane Lyft with Lidocaine for expanding the indications to include injection into the subcutaneous plane in the dorsal hand to correct volume deficit in patients over the age of 21
- Summary
- <a href="http://www.accessdata.fda.gov/cdrh_docs/pdf4/P040024S099B.pdf" target="_new">Summary of Safety and Effectiveness</a>
Current openFDA PMA Record#
- Device
- Restylane Lyft with Lidocaine
- Applicant
- Q-Med AB
- PMA number
- P040024
- Supplement
- S099
- Product code
- PKY
- Generic name
- Implant, dermal, for aesthetic use in the hands
- Decision date
- 2018-05-18
- Decision code
- APPR
- Date received
- 2017-08-29
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for the Restylane Lyft with Lidocaine for expanding the indications to include injection into the subcutaneous plane in the dorsal hand to correct volume deficit in patients over the age of 21