PMA P010003S025
- Device
- BIOGLUE SURGICAL ADHESIVE
- Applicant
- Cryolife, Inc.
- PMA number
- P010003
- Supplement
- S025
- Product code
- MUQ
- Decision date
- 2016-09-08
- Classification
- Glue, Surgical, Arteries
- Generic name
- Glue, surgical, arteries
- Approval order statement
- Reuse of the BioGlue insulated outer shipper for irradiation.
Current openFDA PMA Record#
- Device
- BIOGLUE SURGICAL ADHESIVE
- Applicant
- Cryolife, Inc.
- PMA number
- P010003
- Supplement
- S025
- Product code
- MUQ
- Generic name
- Glue, surgical, arteries
- Decision date
- 2016-09-08
- Decision code
- OK30
- Date received
- 2016-08-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Reuse of the BioGlue insulated outer shipper for irradiation.