SPECTRANECTICS CVX-300 EXCIMER LASER SYSTEM
FDA premarket approval P910001/S084 · decided 2016-04-07
Approval details
- PMA number
- P910001
- Supplement
- S084
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SPECTRANECTICS CVX-300 EXCIMER LASER SYSTEM
- Generic name
- DEVICE, ANGIOPLASTY, LASER, CORONARY
- Applicant
- Spectranetics Corp.
- Date received
- 2016-03-08
- Decision date
- 2016-04-07
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LPC
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Colorado Springs, CO
- Statement
- Changes to the distal jacket manufacturing process.
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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 |