PMA P040024S126

Device
Restylane Injectable Gel
Applicant
Q-Med AB
PMA number
P040024
Supplement
S126
Product code
LMH
Decision date
2021-08-25
Generic name
Implant, dermal, for aesthetic use
Approval order statement
Change in the implementation of interface between ERP system and gLIMS system.

Current openFDA PMA Record#

Device
Restylane Injectable Gel
Applicant
Q-Med AB
PMA number
P040024
Supplement
S126
Product code
LMH
Generic name
Implant, dermal, for aesthetic use
Decision date
2021-08-25
Decision code
OK30
Date received
2021-07-28
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Change in the implementation of interface between ERP system and gLIMS system.