COLLASTAR INSTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENT MICROFIBRILLAR
FDA premarket approval P810006/S048 · decided 2014-03-18
Approval details
- PMA number
- P810006
- Supplement
- S048
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- COLLASTAR INSTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENT MICROFIBRILLAR
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Integra LifeSciences Corporation
- Date received
- 2013-11-01
- Decision date
- 2014-03-18
- Days to decision
- 137 days
- Decision code
- APPR
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Planisboro, NJ
- Statement
- APPROVAL FOR ADDING INCREASED SYSTEM CAPACITY FOR WATER PURIFICATION OF THE CURRENT REVERSE OSMOSIS/ELECTRO-DEIONIZATION WATER PURIFICATION SYSTEM (ROEDI).
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