- Device
- Absorbable Collagen Plug for Dental Surgery, Absorbable Collagen Tape for Dental Surgery
- Applicant
- Integra Lifesciences Corp.
- PMA number
- P840062
- Supplement
- S068
- Product code
- LPG
- Generic name
- MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID
- Decision date
- 2019-02-22
- Decision code
- APPR
- Date received
- 2018-08-27
- 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: Absorbable Collagen Tape for Dental Surgery and Absorbable Collagen Plug for Dental Surgery.