- Device
- CollaCote and CollaTape Absorbable Collagen Wond Dressing for Dental Surgery
- Applicant
- Integra Lifesciences Corp.
- PMA number
- P840062
- Supplement
- S069
- Product code
- LPG
- Generic name
- MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID
- Decision date
- 2019-06-14
- Decision code
- APPR
- Date received
- 2018-10-09
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for the implementation of a new instrument to calculate the percent solids of Alkali Dispersions