COLLACOTE ABSORBABLE COLLAGEN WOUND DRESSING
FDA premarket approval P840062/S018 · decided 2009-03-26
Approval details
- PMA number
- P840062
- Supplement
- S018
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- COLLACOTE ABSORBABLE COLLAGEN WOUND DRESSING
- Generic name
- MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID
- Applicant
- Integra Lifesciences Corp.
- Date received
- 2009-02-02
- Decision date
- 2009-03-26
- Days to decision
- 52 days
- Decision code
- APPR
- Product code
- LPG
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Planisboro, NJ
- Statement
- APPROVAL FOR AN ALTERNATE PRODUCTION FACILITY LOCATED AT INTEGRA NEUROSCIENCES PR, INC., FOR SEVERAL PRODUCTION STEPS FOR THE DEVICES.
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