Collastat Absorbable Collagen Hemostatic Sponge and Collastat Absorbable Collagen Hemostatic Agent Microfibrillar Fo
FDA premarket approval P810006/S106 · decided 2024-02-21
Approval details
- PMA number
- P810006
- Supplement
- S106
- 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 Fo
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Integra LifeSciences Corporation
- Date received
- 2024-01-22
- Decision date
- 2024-02-21
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Planisboro, NJ
- Statement
- qualification of a new external Process Challenge Device, and an update to the quantity of internal and external Process Challenge Devices used in Performance Qualification and routine monitoring of the ethylene oxide sterilization cycle
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.