PMA P840062S066
- Device
- CollaCote, CollaTape, CollaPlug, Absorbable Collagen Wound Dressings for Dental Surgery
- Applicant
- Integra Lifesciences Corp.
- PMA number
- P840062
- Supplement
- S066
- Product code
- LPG
- Decision date
- 2018-05-16
- Classification
- Material, Dressing, Surgical, Polylactic Acid
- Generic name
- MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID
- Approval order statement
- Change in the environmental monitoring procedures for detection of bioburden at the main cleanroom manufacturing area.
Current openFDA PMA Record#
- Device
- CollaCote, CollaTape, CollaPlug, Absorbable Collagen Wound Dressings for Dental Surgery
- Applicant
- Integra Lifesciences Corp.
- PMA number
- P840062
- Supplement
- S066
- Product code
- LPG
- Generic name
- MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID
- Decision date
- 2018-05-16
- Decision code
- OK30
- Date received
- 2018-04-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change in the environmental monitoring procedures for detection of bioburden at the main cleanroom manufacturing area.