CollaCote/ CollaTape/ CollePlug/Absorbable Collegen Wound Dressings
FDA premarket approval P840062/S058 · decided 2016-12-11
Approval details
- PMA number
- P840062
- Supplement
- S058
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CollaCote/ CollaTape/ CollePlug/Absorbable Collegen Wound Dressings
- Generic name
- MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID
- Applicant
- Integra Lifesciences Corp.
- Date received
- 2016-11-07
- Decision date
- 2016-12-11
- Days to decision
- 34 days
- Decision code
- OK30
- Product code
- LPG
- Advisory committee
- Dental
- 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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