TROPHOCAN TM
FDA premarket approval P890024/S001 · decided 1990-08-17
Approval details
- PMA number
- P890024
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- TROPHOCAN TM
- Generic name
- Catheter, sampling, chorionic villus
- Applicant
- Smiths Industries Medical Systems, Inc.
- Date received
- 1990-08-14
- Decision date
- 1990-08-17
- Days to decision
- 3 days
- Decision code
- APPR
- Product code
- LLX
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Keene, NH
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| FENESTRATED FLEXIBLE D.I.C. TRACHEOSTOMY TUBE CUFFED (K972385) | Smiths Industries Medical Systems, Inc. | 1998-01-20 |
| REGIONAL ANESTHESIA TRAYS (K965017) | Smiths Industries Medical Systems, Inc. | 1997-03-14 |
| PORTEX ADJUSTABLE FLANGE TRACHEOSTOMY TUBE (K962175) | Smiths Industries Medical Systems, Inc. | 1997-01-17 |
| SIMS PRO-VENT 250 (500) PLUS ARTERIAL BLOOD SAMPLING KIT (K962931) | Smiths Industries Medical Systems, Inc. | 1996-10-21 |
| SIMS ADULT LUMBAR PUNCTURE KIT (4800-20,4801-20,4806-22,4807-22) (K963570) | Smiths Industries Medical Systems, Inc. | 1996-10-18 |
| PER-FIT PERCUTANEOUS TRACHEOSTOMY KIT W/PORTEX TRACHEOSTMY TUBE & DISP. INNER CANNULA (K960429) | Smiths Industries Medical Systems, Inc. | 1996-05-02 |
| SIMS CPAP SYSTEM (K953485) | Smiths Industries Medical Systems, Inc. | 1995-10-26 |
| SIMS BLUE LINE ENDOBRONCHIAL TUBE (K953483) | Smiths Industries Medical Systems, Inc. | 1995-10-24 |