PMA P960011S010
- Device
- BIOLON 1% SODIUM HYALURONATE FOR OPHTHALMIC SURGERY
- Applicant
- Altacor , Ltd.
- PMA number
- P960011
- Supplement
- S010
- Product code
- LZP
- Decision date
- 2005-09-15
- Classification
- Aid, Surgical, Viscoelastic
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Approval order statement
- APPROVAL TO INCLUDE IOLTECH, CIDRA, PUERTO RICO AS A DISTRIBUTOR FOR BIOLON IN THE UNITED STATES.
Current openFDA PMA Record#
- Device
- BIOLON 1% SODIUM HYALURONATE FOR OPHTHALMIC SURGERY
- Applicant
- Altacor , Ltd.
- PMA number
- P960011
- Supplement
- S010
- Product code
- LZP
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Decision date
- 2005-09-15
- Decision code
- APPR
- Date received
- 2005-05-11
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL TO INCLUDE IOLTECH, CIDRA, PUERTO RICO AS A DISTRIBUTOR FOR BIOLON IN THE UNITED STATES.