PMA P890045S001
- Device
- VASCUTEK GELSOFT(TM) VASCULAR GRAFT
- Applicant
- Carbomedics, Inc.
- PMA number
- P890045
- Supplement
- S001
- Product code
- MAL
- Decision date
- 1995-07-05
- Classification
- Graft, Vascular, Synthetic/biologic Composite
- Generic name
- GRAFT, VASCULAR, SYNTHETIC/BIOLOGIC COMPOSITE
- Approval order statement
- APPLYING THE GELATIN COATING TO THE VASCUSOFT, A DIFFERENT SUBSTRATE GRAFT.THE MODIFIED DEVICE WILL BE MARKETED UNDER TRADE NAME:VASCUTEK GELSOFT VASCULAR GRAFT
Current openFDA PMA Record#
- Device
- VASCUTEK GELSOFT(TM) VASCULAR GRAFT
- Applicant
- Carbomedics, Inc.
- PMA number
- P890045
- Supplement
- S001
- Product code
- MAL
- Generic name
- GRAFT, VASCULAR, SYNTHETIC/BIOLOGIC COMPOSITE
- Decision date
- 1995-07-05
- Decision code
- APPR
- Date received
- 1993-07-08
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPLYING THE GELATIN COATING TO THE VASCUSOFT, A DIFFERENT SUBSTRATE GRAFT.THE MODIFIED DEVICE WILL BE MARKETED UNDER TRADE NAME:VASCUTEK GELSOFT VASCULAR GRAFT