BIOLON
FDA premarket approval P960011/S031 · decided 2019-05-01
Approval details
- PMA number
- P960011
- Supplement
- S031
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BIOLON
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Applicant
- Altacor , Ltd.
- Date received
- 2019-04-04
- Decision date
- 2019-05-01
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- LZP
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Theale
- Statement
- Qualification of an additional chamber and use of a modified ethylene oxide sterilization cycle for the BIOLON® Ophthalmic Viscosurgical Device (OVD).
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