PMA P840062S083
- Device
- CollaCote, CollaTape, and CollaPlug Absorbable Collagen Wound Dressings for Dental Surgery
- Applicant
- Integra Lifesciences Corp.
- PMA number
- P840062
- Supplement
- S083
- Product code
- LPG
- Decision date
- 2021-08-12
- Generic name
- MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID
- Approval order statement
- Qualification of upgrades to the lyophilizer system software and hardware.
Current openFDA PMA Record#
- Device
- CollaCote, CollaTape, and CollaPlug Absorbable Collagen Wound Dressings for Dental Surgery
- Applicant
- Integra Lifesciences Corp.
- PMA number
- P840062
- Supplement
- S083
- Product code
- LPG
- Generic name
- MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID
- Decision date
- 2021-08-12
- Decision code
- OK30
- Date received
- 2021-07-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Qualification of upgrades to the lyophilizer system software and hardware.