COLLACOTE(R),COLLATAPE(R),COLLAPLUG(R), DRESSINGS
FDA premarket approval P840062/S006 · decided 1995-09-08
Approval details
- PMA number
- P840062
- Supplement
- S006
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- COLLACOTE(R),COLLATAPE(R),COLLAPLUG(R), DRESSINGS
- Generic name
- MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID
- Applicant
- Integra Lifesciences Corp.
- Date received
- 1995-07-25
- Decision date
- 1995-09-08
- Days to decision
- 45 days
- Decision code
- APPR
- Product code
- LPG
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Planisboro, NJ
- Statement
- APPROVAL FOR AN ALTERNATE STERILIZATION FACILITY FOR COLLACOTE, COLLATAPE AND COLLAPLUG DRESSINGS AT FRIFFITH MICROSCIENCE, INC., 27 PARK ROAD, GLEN FALLS, NY 12801
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