Collastat Absorbable Collagen Hemostatic Sponge and Collastat Absorbable Collagen Hemostatic Agent - Microfibrillar Form
FDA premarket approval P810006/S110 · decided 2024-08-29
Approval details
- PMA number
- P810006
- Supplement
- S110
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Collastat Absorbable Collagen Hemostatic Sponge and Collastat Absorbable Collagen Hemostatic Agent - Microfibrillar 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
- Planisboro, 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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