PMA P960011S031
- Device
- BIOLON
- Applicant
- Altacor , Ltd.
- PMA number
- P960011
- Supplement
- S031
- Product code
- LZP
- Decision date
- 2019-05-01
- Classification
- Aid, Surgical, Viscoelastic
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Approval order statement
- Qualification of an additional chamber and use of a modified ethylene oxide sterilization cycle for the BIOLON® Ophthalmic Viscosurgical Device (OVD).
Current openFDA PMA Record#
- Device
- BIOLON
- Applicant
- Altacor , Ltd.
- PMA number
- P960011
- Supplement
- S031
- Product code
- LZP
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Decision date
- 2019-05-01
- Decision code
- OK30
- Date received
- 2019-04-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Qualification of an additional chamber and use of a modified ethylene oxide sterilization cycle for the BIOLON® Ophthalmic Viscosurgical Device (OVD).