GIANTURCO-ROUBIN FLEX STENT/GRII(TM) CORONARY STENT
FDA premarket approval P910030/S009 · decided 2002-02-13
Approval details
- PMA number
- P910030
- Supplement
- S009
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- GIANTURCO-ROUBIN FLEX STENT/GRII(TM) CORONARY STENT
- Generic name
- STENT, CORONARY
- Applicant
- Cook, Inc.
- Date received
- 2000-06-13
- Decision date
- 2002-02-13
- Days to decision
- 610 days
- Decision code
- APPR
- Product code
- MAF
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Bloomington, IN
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT COOK, INC., BLOOMINGTON, INDIANA. PACKAGING OF THE DEVICES WILL TAKE PLACE AT THIS FACILITY.
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| FLEXOR RADIAL HYDROPHILIC INTRODUCER ACCESS SET (K132592) | Cook, Inc. | 2014-10-09 |
| CIAGLIA PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY, CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY (K133597) | Cook, Inc. | 2014-04-18 |
| CANTATA(R) 2.9 MICROCATHETER (K131772) | Cook, Inc. | 2014-02-20 |
| ADVANCE CS CORONARY SINUS INFUSION CATHETER (K131204) | Cook, Inc. | 2014-01-29 |
| SPECTRUM TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET (K133634) | Cook, Inc. | 2013-12-23 |
| ADVANCE 34LP LOW PROFILE PTA BALLOON DILATATION CATHETER (K132020) | Cook, Inc. | 2013-10-25 |