PMA P850049S007
- Device
- GIANTURCO-ROEHM BIRD'S NEST VENA CAVA FILTER
- Applicant
- Cook, Inc.
- PMA number
- P850049
- Supplement
- S007
- Product code
- DTK
- Decision date
- 1999-09-14
- Generic name
- FILTER, INTRAVASCULAR, CARDIOVASCULAR
- Approval order statement
- Approval to add a Patient Guide booklet to each device shipment.
Current openFDA PMA Record#
- Device
- GIANTURCO-ROEHM BIRD'S NEST VENA CAVA FILTER
- Applicant
- Cook, Inc.
- PMA number
- P850049
- Supplement
- S007
- Product code
- DTK
- Generic name
- FILTER, INTRAVASCULAR, CARDIOVASCULAR
- Decision date
- 1999-09-14
- Decision code
- APPR
- Date received
- 1999-08-20
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval to add a Patient Guide booklet to each device shipment.