Helistat Absorbable Collagen Hemostatic Agent and Helitene Absorbable Collagen Hemostatic Agent - Fibrillar Form
FDA premarket approval P850010/S113 · decided 2024-08-29
Approval details
- PMA number
- P850010
- Supplement
- S113
- 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
- 2024-08-01
- Decision date
- 2024-08-29
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Plainsboro, NJ
- Statement
- change the seal strength and sterile barrier system integrity testing from visual Burst and Creep methods to testing per ASTM F88/F88M to comply with ISO 11607
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