- Device
- CollaCote, CollaTape, CollaPlug, Absorbable Collagen Wound Dressings for Dental Surgery
- Applicant
- Integra Lifesciences Corp.
- PMA number
- P840062
- Supplement
- S080
- Product code
- LPG
- Generic name
- MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID
- Decision date
- 2021-09-07
- Decision code
- APPR
- Date received
- 2021-03-30
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for the removal of Heavy Metals testing from the routine monitoring of their Purified Water System used in the product manufacturing at their Puerto Rico facility