PMA P840062S076
- Device
- CollaCote, CollaTape, CollaTape, CollaPlug, Absorbable Collagen Wound Dressings for Dental Surgery
- Applicant
- Integra Lifesciences Corp.
- PMA number
- P840062
- Supplement
- S076
- Product code
- LPG
- Decision date
- 2019-06-27
- Classification
- Material, Dressing, Surgical, Polylactic Acid
- Generic name
- MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID
- Approval order statement
- Equipment modifications and introduction of a one-piece flow methodology within the Cutting, Inspection and Packaging room within the Collagen Manufacturing Center located at 105 Morgan Lane, Plainsboro, New Jersey.
Current openFDA PMA Record#
- Device
- CollaCote, CollaTape, CollaTape, CollaPlug, Absorbable Collagen Wound Dressings for Dental Surgery
- Applicant
- Integra Lifesciences Corp.
- PMA number
- P840062
- Supplement
- S076
- Product code
- LPG
- Generic name
- MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID
- Decision date
- 2019-06-27
- Decision code
- OK30
- Date received
- 2019-05-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Equipment modifications and introduction of a one-piece flow methodology within the Cutting, Inspection and Packaging room within the Collagen Manufacturing Center located at 105 Morgan Lane, Plainsboro, New Jersey.