Collastat Absorbable Collagen Hemostatic Sponge and Collastat Absorbable Collagen Hemostatic Agent Microfibrillar Form
FDA premarket approval P810006/S096 · decided 2021-11-13
Approval details
- PMA number
- P810006
- Supplement
- S096
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- 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
- 2021-05-24
- Decision date
- 2021-11-13
- Days to decision
- 173 days
- Decision code
- APPR
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Planisboro, NJ
- Statement
- Approval for the qualification of an additional abattoir (harvesting facility) for New Zealand sourced bovine tendon.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.