PMA P040024S118

Device
Restylane Injectable Gels
Applicant
Q-Med AB
PMA number
P040024
Supplement
S118
Product code
LMH
Decision date
2020-02-27
Generic name
Implant, dermal, for aesthetic use
Approval order statement
Replacement of a window/wall section with a new door in Q-Med's Facility Line 1 (L1) located in Building 3 at Seminariegatan 21, SE-752 28 Uppsala, Sweden.

Current openFDA PMA Record#

Device
Restylane Injectable Gels
Applicant
Q-Med AB
PMA number
P040024
Supplement
S118
Product code
LMH
Generic name
Implant, dermal, for aesthetic use
Decision date
2020-02-27
Decision code
OK30
Date received
2020-01-28
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Replacement of a window/wall section with a new door in Q-Med's Facility Line 1 (L1) located in Building 3 at Seminariegatan 21, SE-752 28 Uppsala, Sweden.