PMA P130004S005

Device
RESURE SEALANT
Applicant
Ocular Therapeutix, Inc.
PMA number
P130004
Supplement
S005
Product code
PFZ
Decision date
2014-10-10
Classification
Ophthalmic Sealant
Generic name
Ophthalmic Sealant
Approval order statement
CRITICAL SUPPLIER LOCATION CHANGE- ADDITIONAL FACILITY FOR JENKEM.

Current openFDA PMA Record#

Device
RESURE SEALANT
Applicant
Ocular Therapeutix, Inc.
PMA number
P130004
Supplement
S005
Product code
PFZ
Generic name
Ophthalmic Sealant
Decision date
2014-10-10
Decision code
OK30
Date received
2014-09-09
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
CRITICAL SUPPLIER LOCATION CHANGE- ADDITIONAL FACILITY FOR JENKEM.