PMA P850049S008
- Device
- GIANTURCO-ROEHM BIRD'S NEST(TM) VENA CAVA FILTER
- Applicant
- Cook, Inc.
- PMA number
- P850049
- Supplement
- S008
- Product code
- DTK
- Decision date
- 2002-02-13
- Classification
- Cardiovascular
- Generic name
- FILTER, INTRAVASCULAR, CARDIOVASCULAR
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT COOK INC., BLOOMINGTON, INDIANA.
Current openFDA PMA Record#
- Device
- GIANTURCO-ROEHM BIRD'S NEST(TM) VENA CAVA FILTER
- Applicant
- Cook, Inc.
- PMA number
- P850049
- Supplement
- S008
- Product code
- DTK
- Generic name
- FILTER, INTRAVASCULAR, CARDIOVASCULAR
- Decision date
- 2002-02-13
- Decision code
- APPR
- Date received
- 2000-06-13
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT COOK INC., BLOOMINGTON, INDIANA.