- Device
- CollaCote, CollaTape, CollaPlug, Absorbable Collagen Wound Dressings for Dental Surgery
- Applicant
- Integra Lifesciences Corp.
- PMA number
- P840062
- Supplement
- S093
- Product code
- LPG
- Generic name
- MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID
- Decision date
- 2024-08-29
- Decision code
- OK30
- Date received
- 2024-08-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- change the seal strength and sterile barrier system integrity testing from visual “Burst” and “Creep” methods to testing per ASTM F88/F88M to comply with ISO 11607