PMA P000046S028

Device
Ophthalmic
Applicant
Anika Therapeutics, Inc.
PMA number
P000046
Supplement
S028
Product code
LZP
Decision date
2021-06-02
Generic name
AID, SURGICAL, VISCOELASTIC
Approval order statement
Use of an alternate stopper from the current supplier for the syringe that holds your approved ophthalmic viscosurgical device.

Current openFDA PMA Record#

Device
Ophthalmic
Applicant
Anika Therapeutics, Inc.
PMA number
P000046
Supplement
S028
Product code
LZP
Generic name
AID, SURGICAL, VISCOELASTIC
Decision date
2021-06-02
Decision code
OK30
Date received
2021-05-04
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Use of an alternate stopper from the current supplier for the syringe that holds your approved ophthalmic viscosurgical device.