COLLACOTE,COLLATAPE,COLLAPLUG ABSORABLE COLLAGEN WOUND DRESS
FDA premarket approval P840062/S040 · decided 2014-10-17
Approval details
- PMA number
- P840062
- Supplement
- S040
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- COLLACOTE,COLLATAPE,COLLAPLUG ABSORABLE COLLAGEN WOUND DRESS
- Generic name
- MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID
- Applicant
- Integra Lifesciences Corp.
- Date received
- 2014-04-11
- Decision date
- 2014-10-17
- Days to decision
- 189 days
- Decision code
- APPR
- Product code
- LPG
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Planisboro, NJ
- Statement
- APPROVAL FOR THE IMPLEMENTATION OF MECHANICAL, PROGRAM, AND SYSTEM CONTROL CHANGES TO THE EXISTING CHILLED WATER SYSTEM THAT SERVICES COLLAGEN LYOPHILIZER MACHINES IN THE LYO MANUFACTURING AREA OF BUILDING 1 AT THE INTEGRA NEUROSCIENCES FACILITY IN AÑASCO, PUERTO RICO, FOR THE DEVICES.
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