GIANTURCO-ROUBIN CORONARY FLEX-STENT(TM) 12MM LONG
FDA premarket approval P910030/S008 · decided 1998-05-05
Approval details
- PMA number
- P910030
- Supplement
- S008
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- GIANTURCO-ROUBIN CORONARY FLEX-STENT(TM) 12MM LONG
- Generic name
- STENT, CORONARY
- Applicant
- Cook, Inc.
- Date received
- 1998-01-28
- Decision date
- 1998-05-05
- Days to decision
- 97 days
- Decision code
- APPR
- Product code
- MAF
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Bloomington, IN
- Statement
- Approval for a labeling change in the Instructions for Use ("Technical Information and Suggested Instructions for Placement") of the GR II(TM) Coronary Stent.
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