Collastat Absorbable Collagen Hemostatic Sponge and Collastat Absorbable Hemostatic Agent - Microfibrillar Form
FDA premarket approval P810006/S086 · decided 2019-04-26
Approval details
- PMA number
- P810006
- Supplement
- S086
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Collastat Absorbable Collagen Hemostatic Sponge and Collastat Absorbable Hemostatic Agent - Microfibrillar Form
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Integra LifeSciences Corporation
- Date received
- 2019-03-27
- Decision date
- 2019-04-26
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Planisboro, NJ
- Statement
- Splitting an existing Clean Compressed Air (CCA) Point of Use (POU) within Room 105. You split the existing POU into two (2) POUs with one POU dedicated to filter integrity testing and the other POU dedicated to equipment drying.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.