Collastat Absorbable Collagen Hemostatic Sponge and Collastat Absorbable Collagen Hemostatic- Microfibrillar Form
FDA premarket approval P810006/S085 · decided 2019-04-19
Approval details
- PMA number
- P810006
- Supplement
- S085
- 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- Microfibrillar Form
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Integra LifeSciences Corporation
- Date received
- 2019-03-21
- Decision date
- 2019-04-19
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Planisboro, NJ
- Statement
- Implementation of data integrity and security controls for the Quality Control (QC) Analytical Laboratory Instruments at the Collagen Manufacturing Center (CMC).
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.