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PMA P040047S061

Device
COAPTITE Injectable Implant
Applicant
Merz North America, Inc.
PMA number
P040047
Supplement
S061
Product code
LNM
Decision date
2020-10-15
Generic name
AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
Approval order statement
Adding Merz North America as an alternate facility to perform microbial analysis of water in the microbiology laboratory at manufacturing sites of COAPTITE, RADIESSE, and RADIESSE (+) Lidocaine.

Current openFDA PMA Record#

Device
COAPTITE Injectable Implant
Applicant
Merz North America, Inc.
PMA number
P040047
Supplement
S061
Product code
LNM
Generic name
AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
Decision date
2020-10-15
Decision code
OK30
Date received
2020-09-18
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Adding Merz North America as an alternate facility to perform microbial analysis of water in the microbiology laboratory at manufacturing sites of COAPTITE, RADIESSE, and RADIESSE (+) Lidocaine.