PMA P040024S134

Device: RESTYLANE® Injectable Gels
Applicant: Q-Med AB
PMA number: P040024
Supplement: S134
Product code: LMH
Decision date: 2022-09-30
Generic name: Implant, dermal, for aesthetic use
Approval order statement: Add a permanent transverse wall between cleanrooms 9:175 and 9:176 in manufacturing L3 for Restylane®, Restylane®-L, Restylane® Lyft with Lidocaine, Perlane® and Restylane® Silk production.

Current openFDA PMA Record#

Device: RESTYLANE® Injectable Gels
Applicant: Q-Med AB
PMA number: P040024
Supplement: S134
Product code: LMH
Generic name: Implant, dermal, for aesthetic use
Decision date: 2022-09-30
Decision code: OK30
Date received: 2022-09-07
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Add a permanent transverse wall between cleanrooms 9:175 and 9:176 in manufacturing L3 for Restylane®, Restylane®-L, Restylane® Lyft with Lidocaine, Perlane® and Restylane® Silk production.