PMA P890045S005
- Device
- VASCUTEK GELSEAL(TM) VASCULAR GRAFT
- Applicant
- Carbomedics, Inc.
- PMA number
- P890045
- Supplement
- S005
- Product code
- MAL
- Decision date
- 1995-04-13
- Classification
- Graft, Vascular, Synthetic/biologic Composite
- Generic name
- GRAFT, VASCULAR, SYNTHETIC/BIOLOGIC COMPOSITE
Current openFDA PMA Record#
- Device
- VASCUTEK GELSEAL(TM) VASCULAR GRAFT
- Applicant
- Carbomedics, Inc.
- PMA number
- P890045
- Supplement
- S005
- Product code
- MAL
- Generic name
- GRAFT, VASCULAR, SYNTHETIC/BIOLOGIC COMPOSITE
- Decision date
- 1995-04-13
- Decision code
- APPR
- Date received
- 1994-03-31
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename