HELISTAT ABSORABABLE COLLAGEN HEMOSTATIC AGENT MICROFIBRILLAR
FDA premarket approval P850010/S044 · decided 2014-04-08
Approval details
- PMA number
- P850010
- Supplement
- S044
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- HELISTAT ABSORABABLE COLLAGEN HEMOSTATIC AGENT MICROFIBRILLAR
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Integra LifeSciences Corporation
- Date received
- 2013-08-14
- Decision date
- 2014-04-08
- Days to decision
- 237 days
- Decision code
- APPR
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Plainsboro, NJ
- Statement
- APPROVAL FOR THE FOLLOWING PROPOSED CHANGES: 1) CLEANING VALIDATION FOR THE MICROFIBRILLAR GRINDING PROCESS EQUIPMENT; 2) ESTABLISHMENT OF DIRTY HOLD TIME;3) TOTAL ORGANIC CARBON (TOC) RECOVERY STUDY FOR SWAB AND RINSE ON STAINLESS STEEL SURFACES; AND4) TOC RECOVERY STUDY FOR SWAB AND RINSE ON TEFLON SURFACES.
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