PMA P860047S031
- Device
- OCUCOAT OPHTHALMIC VISCOSURGICAL DEVICE
- Applicant
- Bausch & Lomb, Inc.
- PMA number
- P860047
- Supplement
- S031
- Product code
- LZP
- Decision date
- 2015-09-25
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Approval order statement
- APPROVAL TO CHANGE THE CANNULA ON THE 1 ML OCUCOAT 2% HYDROXYPROPYLMETHYLCELLULOSE OPHTHALMIC SURGICAL DEVICE TO A 25 GAUGE NEEDLE WITH A 32 DEGREE BEND.
Current openFDA PMA Record#
- Device
- OCUCOAT OPHTHALMIC VISCOSURGICAL DEVICE
- Applicant
- Bausch & Lomb, Inc.
- PMA number
- P860047
- Supplement
- S031
- Product code
- LZP
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Decision date
- 2015-09-25
- Decision code
- APPR
- Date received
- 2015-07-01
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL TO CHANGE THE CANNULA ON THE 1 ML OCUCOAT 2% HYDROXYPROPYLMETHYLCELLULOSE OPHTHALMIC SURGICAL DEVICE TO A 25 GAUGE NEEDLE WITH A 32 DEGREE BEND.