FDA.reportPublic FDA data

PMA P040024S121

Device
Restylane, Restylane-L, Perlane, Restylane Lyft with Lidocaine, Restylane Silk
Applicant
Q-Med AB
PMA number
P040024
Supplement
S121
Product code
LMH
Decision date
2020-11-06
Generic name
Implant, dermal, for aesthetic use
Approval order statement
Changes to the distribution systems for Water for Injection (WFI) and changes to producer and distribution system of compressed air in Line 1 (L1) at Q-Med ABUppsala used for the manufacture of Restylane and Perlane.

Current openFDA PMA Record#

Device
Restylane, Restylane-L, Perlane, Restylane Lyft with Lidocaine, Restylane Silk
Applicant
Q-Med AB
PMA number
P040024
Supplement
S121
Product code
LMH
Generic name
Implant, dermal, for aesthetic use
Decision date
2020-11-06
Decision code
OK30
Date received
2020-10-07
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Changes to the distribution systems for Water for Injection (WFI) and changes to producer and distribution system of compressed air in Line 1 (L1) at Q-Med ABUppsala used for the manufacture of Restylane and Perlane.