PMA P840062S073
- Device
- CollaCote, CollaTape, and CollaPlug Absorbable Collagen Wound Dressings for Dental Surgergy
- Applicant
- Integra Lifesciences Corp.
- PMA number
- P840062
- Supplement
- S073
- Product code
- LPG
- Decision date
- 2019-04-26
- Classification
- Material, Dressing, Surgical, Polylactic Acid
- Generic name
- MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID
- Approval order statement
- Splitting an existing Clean Compressed Air (CCA) Point of Use (POU) within Room 105. You split the existing POU into two (2) POUs with one POU dedicated to filter integrity testing and the other POU dedicated to equipment drying.
Current openFDA PMA Record#
- Device
- CollaCote, CollaTape, and CollaPlug Absorbable Collagen Wound Dressings for Dental Surgergy
- Applicant
- Integra Lifesciences Corp.
- PMA number
- P840062
- Supplement
- S073
- Product code
- LPG
- Generic name
- MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID
- Decision date
- 2019-04-26
- Decision code
- OK30
- Date received
- 2019-03-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Splitting an existing Clean Compressed Air (CCA) Point of Use (POU) within Room 105. You split the existing POU into two (2) POUs with one POU dedicated to filter integrity testing and the other POU dedicated to equipment drying.