PMA P080013S021
- Device
- DuraSeal Exact Spine Sealant System
- Applicant
- Integra LifeSciences Corporation
- PMA number
- P080013
- Supplement
- S021
- Product code
- NQR
- Decision date
- 2020-09-16
- Generic name
- Sealant, dural
- Approval order statement
- Move the production of the packaging from Building #1 to Building #2.
Current openFDA PMA Record#
- Device
- DuraSeal Exact Spine Sealant System
- Applicant
- Integra LifeSciences Corporation
- PMA number
- P080013
- Supplement
- S021
- Product code
- NQR
- Generic name
- Sealant, dural
- Decision date
- 2020-09-16
- Decision code
- OK30
- Date received
- 2020-08-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Move the production of the packaging from Building #1 to Building #2.