GIANTURCO-ROUBIN CORONARY FLEX-STENT(TM)
FDA premarket approval P910030/S002 · decided 1994-01-27
Approval details
- PMA number
- P910030
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- GIANTURCO-ROUBIN CORONARY FLEX-STENT(TM)
- Generic name
- STENT, CORONARY
- Applicant
- Cook, Inc.
- Date received
- 1993-12-14
- Decision date
- 1994-01-27
- Days to decision
- 44 days
- Decision code
- APPR
- Product code
- MAF
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Bloomington, IN
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| SPECTRUM TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET (K133634) | Cook, Inc. | 2013-12-23 |
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