Collastat Absorbable Collagen Hemostatic Sponge and Collastat Absorbable Collagen Hemostatic Agent - Microfibrillar Fo
Integra LifeSciences Corporation · Agent, absorbable hemostatic, collagen based · General, Plastic Surgery
Open FDA's page for this record- PMA number
- P810006
- Supplement number
- S115
- Applicant
- Integra LifeSciences Corporation
- Street 1
- 311 Enterprise Dr.
- City
- Planisboro
- State
- NJ
- Zip
- 08536
- Generic name
- Agent, absorbable hemostatic, collagen based
- Trade name
- Collastat Absorbable Collagen Hemostatic Sponge and Collastat Absorbable Collagen Hemostatic Agent - Microfibrillar Fo
- Product code
- LMF
- Advisory committee
- SU
- Advisory committee description
- General, Plastic Surgery
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited review flag
- N
- Date received
- 2026-08-21
- Decision date
- 2026-09-18
- Decision code
- OK30
- Ao statement
- installation and qualification of a new Water for Injection (WFI) pretreatment, generation, storage, and distribution system
- Harmonized identifiers (openFDA)
- Device name
- Agent, Absorbable Hemostatic, Collagen Based
- Medical specialty description
- General, Plastic Surgery
- Regulation number
- 878.4490
- Device class
- 3
- Registration number
- 1121308, 3007162296, 3012421607, 1225991, 2953359, 2024024, 3012187973, 3007766601, 3016844398, 2528981, 2029275, 1000150646, 3006405073, 3011137372, 3008478369, 3009337401, 1416980, 1223089, 1810189, 3011689956, 3014272734, 2011171, 2648988, 3002907620, 2650143, 3002807315, 2937398, 1213643, 3035387162, 3014461810, 3003418325, 3010132111, 1319639, 2134812
- FEI number
- 1121308, 1000306431, 3007162296, 3012421607, 2024024, 3007766601, 3012187973, 3016844398, 3000215205, 2528981, 2648209, 3002827704, 3006405073, 3000204775, 3008478369, 3009337401, 1416980, 1810189, 3011689956, 3014272734, 2011171, 3005747797, 3002907620, 3002516348, 3002807315, 1000120505, 2937398, 1213643, 3004393730, 3014461810, 3003418325, 3010132111, 3035387162, 1000138054