Helistat® Absorbable Collagen Hemostatic Agent and Helitene® Absorbable Collagen Hemostatic Agent Fibrillar Form
FDA premarket approval P850010/S115 · decided 2025-02-18
Approval details
- PMA number
- P850010
- Supplement
- S115
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Helistat® Absorbable Collagen Hemostatic Agent and Helitene® Absorbable Collagen Hemostatic Agent Fibrillar Form
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Integra LifeSciences Corporation
- Date received
- 2025-01-21
- Decision date
- 2025-02-18
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Plainsboro, NJ
- Statement
- for the qualification of the Building 105 Supervisory Application Control and Data Acquisition (SCADA) system and the modifications to the four existing AT Kettle thermocouples
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