PMA P910030
- Device
- Gianturco-roubin Coronary Flex-stent(tm) 12mm Long
- Applicant
- COOK, INC.
- PMA number
- P910030
- Supplement
- S008
- Decision date
- 1998-05-05
Current openFDA PMA Record
- Device
- GIANTURCO-ROUBIN FLEX STENT/GRII(TM) CORONARY STENT
- Applicant
- Cook, Inc.
- PMA number
- P910030
- Supplement
- S009
- Product code
- MAF
- Generic name
- STENT, CORONARY
- Decision date
- 2002-02-13
- Decision code
- APPR
- Date received
- 2000-06-13
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT COOK, INC., BLOOMINGTON, INDIANA. PACKAGING OF THE DEVICES WILL TAKE PLACE AT THIS FACILITY.