BIOLON 1% SODIUM HYALURONATE
FDA premarket approval P960011/S003 · decided 1999-09-02
Approval details
- PMA number
- P960011
- Supplement
- S003
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BIOLON 1% SODIUM HYALURONATE
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Applicant
- Altacor , Ltd.
- Date received
- 1999-08-03
- Decision date
- 1999-09-02
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LZP
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Theale
- Statement
- The 30-Day Notice requested a manufacturing process change for BioLon(TM) (1% sodium hyaluronate). The requested change describes the installation and qualification of an upgrade to Bio-Technology General Corporation's fermentation process at the Rehovot, Israel facility and the validation of the sodium hyaluronate fermentation process after the upgrade.
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