COLLASTAT
FDA premarket approval P810006/S070 · decided 2016-03-17
Approval details
- PMA number
- P810006
- Supplement
- S070
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- COLLASTAT
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Integra LifeSciences Corporation
- Date received
- 2016-02-19
- Decision date
- 2016-03-17
- 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 the current Wet Processing Dispersion Tanks #3 and #4, located in the 105 Morgan Lane Medical Manufacturing Suite Room 407, used to produce collagen dispersions for medical devices. Both of these tanks will be replaced by Wet Processing Dispersion Tanks #6 and #5, respectively. Both tanks are fabricated by the same vendor and according to the same specifications and drawings as the existing tank.
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