PMA P130004S001

Device
RESURE SEALANT
Applicant
Ocular Therapeutix, Inc.
PMA number
P130004
Supplement
S001
Product code
PFZ
Decision date
2014-10-02
Classification
Ophthalmic Sealant
Generic name
Ophthalmic Sealant
Approval order statement
APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.

Current openFDA PMA Record#

Device
RESURE SEALANT
Applicant
Ocular Therapeutix, Inc.
PMA number
P130004
Supplement
S001
Product code
PFZ
Generic name
Ophthalmic Sealant
Decision date
2014-10-02
Decision code
APPR
Date received
2014-02-07
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Postapproval Study Protocol - OSB
Approval order statement
APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.