PMA P910030
- Device
- GIANTURCO-ROUBIN FLEX STENT/GRII(TM) CORONARY STENT
- Applicant
- Cook, Inc.
- PMA number
- P910030
- Supplement
- S008
- Product code
- MAF
- Decision date
- 2002-02-13
- Generic name
- STENT, CORONARY
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT COOK, INC., BLOOMINGTON, INDIANA. PACKAGING OF THE DEVICES WILL TAKE PLACE AT THIS FACILITY.
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.