Helistat, Helitene Absorbable Collagen Hemostatic Agents
FDA premarket approval P850010/S081 · decided 2018-05-17
Approval details
- PMA number
- P850010
- Supplement
- S081
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Helistat, Helitene Absorbable Collagen Hemostatic Agents
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Integra LifeSciences Corporation
- Date received
- 2018-04-20
- Decision date
- 2018-05-17
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Plainsboro, NJ
- Statement
- Change in the environmental monitoring procedures for detection of bioburden at the main cleanroom manufacturing area.
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