BIOLON (1% SODIUM HYALURONATE FOR OPHTHALMIC SURGERY)
FDA premarket approval P960011/S009 · decided 2005-01-27
Approval details
- PMA number
- P960011
- Supplement
- S009
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- BIOLON (1% SODIUM HYALURONATE FOR OPHTHALMIC SURGERY)
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Applicant
- Altacor , Ltd.
- Date received
- 2004-07-09
- Decision date
- 2005-01-27
- Days to decision
- 202 days
- Decision code
- APPR
- Product code
- LZP
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Theale
- Statement
- APPROVAL FOR A CHANGE IN MANUFACTURING SITE TO THE BIO-TECHNOLOGY GENERAL, LTD. FACILITY IN BE'ER TUVIA, ISRAEL, AND FOR A CHANGE IN THE SPECIFICATIONS FOR THE ACTIVE PHARMACEUTICAL PRODUCT IN BIOLON.
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