Collastat Absorbable Collagen Hemostatic Sponge, Collastat Absorbable Collagen Hemostatic Agent-Microfibrillar Form (I
FDA premarket approval P810006/S108 · decided 2024-07-24
Approval details
- PMA number
- P810006
- Supplement
- S108
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Collastat Absorbable Collagen Hemostatic Sponge, Collastat Absorbable Collagen Hemostatic Agent-Microfibrillar Form (I
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Integra LifeSciences Corporation
- Date received
- 2024-06-24
- Decision date
- 2024-07-24
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Planisboro, NJ
- Statement
- implementation of the Vaisala viewLinc Countinous Monitoring system for temperature and relative humidity monitoring of manufacturing cleanrooms and laboratory rooms at the Integra NeuroSciences Anasco, PR facility
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