HELISTAT,HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENTS
FDA premarket approval P850010/S071 · decided 2016-06-22
Approval details
- PMA number
- P850010
- Supplement
- S071
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- HELISTAT,HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENTS
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Integra LifeSciences Corporation
- Date received
- 2016-05-25
- Decision date
- 2016-06-22
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Plainsboro, NJ
- Statement
- Create a new procedure, Cutting and Inspection Procedure - ACS, for the cutting and inspection of Absorbable Collagen Sponge (ACS)-(EU) used as a component of the InductOs marketed in the European Union (EU) product in room 304, 105 Morgan Lane, Plainsboro, New Jersey. This procedure directs operators to cull out and reject any cut collagen sponge that has visible foreign matter embedded in or on the surface of the collagen sponge during the inspection process. In addition, a procedure, Packagin
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