PMA P010003S012
- Device
- BIOGLUE
- Applicant
- Cryolife, Inc.
- PMA number
- P010003
- Supplement
- S012
- Product code
- MUQ
- Decision date
- 2008-06-24
- Classification
- Glue, Surgical, Arteries
- Generic name
- Glue, surgical, arteries
- Approval order statement
- ADDITION OF AN AUTOMATED PUMP FOR DISPENSING BOVINE SERUM ALBUMIN AND GLUTERALDEHYDE IN THE MANUFACTURE OF BIOGLUE® SURGICAL ADHESIVE.
Current openFDA PMA Record#
- Device
- BIOGLUE
- Applicant
- Cryolife, Inc.
- PMA number
- P010003
- Supplement
- S012
- Product code
- MUQ
- Generic name
- Glue, surgical, arteries
- Decision date
- 2008-06-24
- Decision code
- OK30
- Date received
- 2008-06-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADDITION OF AN AUTOMATED PUMP FOR DISPENSING BOVINE SERUM ALBUMIN AND GLUTERALDEHYDE IN THE MANUFACTURE OF BIOGLUE® SURGICAL ADHESIVE.