- Device
- CollaCote, CollaTape, CollaPlug Absorbable Collagen Wound Dressings for Dental Surgery
- Applicant
- Integra Lifesciences Corp.
- PMA number
- P840062
- Supplement
- S067
- Product code
- LPG
- Generic name
- MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID
- Decision date
- 2018-08-30
- Decision code
- APPR
- Date received
- 2018-05-01
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for additional trade names: creos xenocote, creos xenotape, and creos xenoplug Absorbable Collagen Wound Dressings for Dental Surgery.