SPECTRANECTICS CVX-300 EXCIMER LASER SYSTEM
FDA premarket approval P910001/S085 · decided 2016-04-13
Approval details
- PMA number
- P910001
- Supplement
- S085
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- SPECTRANECTICS CVX-300 EXCIMER LASER SYSTEM
- Generic name
- DEVICE, ANGIOPLASTY, LASER, CORONARY
- Applicant
- Spectranetics Corp.
- Date received
- 2016-03-14
- Decision date
- 2016-04-13
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- LPC
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Colorado Springs, CO
- Statement
- Approval for the addition of warnings to the Directions for Use (DFU) of the associated Laser Catheters included in the Laser System.
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 |
|---|---|---|
| LEXICONTURE MECHANICAL DILATOR SHEATH SET (K140047) | Spectranetics Corp. | 2014-04-09 |
| 2.5MM TURBO ELITE 035, 2.3MM TURBO ELITE 035 (K123632) | Spectranetics Corp. | 2013-01-25 |
| 8FR TURBO - TANDEM SYSTEM (K112032) | Spectranetics Corp. | 2011-10-17 |
| TORQMAX SHEATH GRIP ACCESSORY (K093257) | Spectranetics Corp. | 2010-03-26 |
| TURBO-TANDEM SYSTEM MODEL 472-110 (K094036) | Spectranetics Corp. | 2010-01-25 |
| SPECTRANETICS VISISHEATH DILATOR SHEATH (K092378) | Spectranetics Corp. | 2009-11-02 |
| SPECTRANETICS QUICK CROSS EXTREME SUPPORT CATHETERS (K092396) | Spectranetics Corp. | 2009-09-04 |
| SPECTRANETICS TURBO-TANDEM SYSTEM (K091299) | Spectranetics Corp. | 2009-07-01 |