- Device
- CollaCote®, CollaTape®, CollaPlug®, Absorbable Collagen Wound Dressings for Dental Surgery
- Applicant
- Integra Lifesciences Corp.
- PMA number
- P840062
- Supplement
- S092
- Product code
- LPG
- Generic name
- MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID
- Decision date
- 2024-07-24
- Decision code
- OK30
- Date received
- 2024-06-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- implementation of the Vaisala viewLinc Countinous Monitoring system for temperature and relative humidity monitoring of manufacturing cleanrooms and laboratory rooms at the Integra NeuroSciences Anasco, PR facility