COLLASTAT / INSTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS
FDA premarket approval P810006/S073 · decided 2016-09-15
Approval details
- PMA number
- P810006
- Supplement
- S073
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- COLLASTAT / INSTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Integra LifeSciences Corporation
- Date received
- 2016-08-19
- Decision date
- 2016-09-15
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Planisboro, NJ
- Statement
- Replacement of a portion of the water deionization system located in the Collagen Manufacturing Center at 105 Morgan Lane, Plainsboro, New Jersey, 08536.
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