PMA P840062S072
- Device
- CollaCote(TM), CollaTape, and CollaPlug Absorbable Collagen Wound Dressings for Dental Surgery
- Applicant
- Integra Lifesciences Corp.
- PMA number
- P840062
- Supplement
- S072
- Product code
- LPG
- Decision date
- 2019-04-19
- Classification
- Material, Dressing, Surgical, Polylactic Acid
- Generic name
- MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID
- Approval order statement
- Implementation of data integrity and security controls for the Quality Control (QC) Analytical Laboratory Instruments at the Collagen Manufacturing Center (CMC).
Current openFDA PMA Record#
- Device
- CollaCote(TM), CollaTape, and CollaPlug Absorbable Collagen Wound Dressings for Dental Surgery
- Applicant
- Integra Lifesciences Corp.
- PMA number
- P840062
- Supplement
- S072
- Product code
- LPG
- Generic name
- MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID
- Decision date
- 2019-04-19
- Decision code
- OK30
- Date received
- 2019-03-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implementation of data integrity and security controls for the Quality Control (QC) Analytical Laboratory Instruments at the Collagen Manufacturing Center (CMC).