PMA P140029S021
- Device
- Restylane® Kysse
- Applicant
- Q-Med AB
- PMA number
- P140029
- Supplement
- S021
- Product code
- LMH
- Decision date
- 2020-03-26
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- Approval for Restylane Kysse. The device is intended for injection into the lips for lip augmentation and for correction of upper perioral rhytids in patients over the age of 21.
- Summary
- <a href="http://www.accessdata.fda.gov/cdrh_docs/pdf14/P140029S021B.pdf" target="_new">Summary of Safety and Effectiveness</a>
Current openFDA PMA Record#
- Device
- Restylane® Kysse
- Applicant
- Q-Med AB
- PMA number
- P140029
- Supplement
- S021
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2020-03-26
- Decision code
- APPR
- Date received
- 2019-09-03
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for Restylane Kysse. The device is intended for injection into the lips for lip augmentation and for correction of upper perioral rhytids in patients over the age of 21.