COLLASTAT INSTAT ABSORABLE COLLAGEN HOMESTATIC AGENTS
FDA premarket approval P810006/S074 · decided 2016-12-07
Approval details
- PMA number
- P810006
- Supplement
- S074
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- COLLASTAT INSTAT ABSORABLE COLLAGEN HOMESTATIC AGENTS
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Integra LifeSciences Corporation
- Date received
- 2016-11-07
- Decision date
- 2016-12-07
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Planisboro, NJ
- Statement
- Clearance for an Electronic Chart Recorder (E-Chart System) for the Hull 2 and Hull 3 Lyophilizer (freeze dryer). The E-Chart system provides visualization, data acquisition, trouble shooting, and trending capabilities of the Hull 2 and 3 lyophilization process to maintenance and engineering personnel. This system is meant to supplement but not replace the current Yokogawa paper chart recorders on these lines, which collect and plot lyophilization process parameters but have no storage or inform
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