Spectranetics Laser Sheath (SLS)
FDA premarket approval P910001/S112 · decided 2021-09-02
Approval details
- PMA number
- P910001
- Supplement
- S112
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Spectranetics Laser Sheath (SLS)
- Generic name
- DEVICE, ANGIOPLASTY, LASER, CORONARY
- Applicant
- Spectranetics Corp.
- Date received
- 2021-01-25
- Decision date
- 2021-09-02
- Days to decision
- 220 days
- Decision code
- APPR
- Product code
- LPC
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Colorado Springs, CO
- Statement
- Approval for the next generation Philips Laser System (PLS), including compatibility with the ELCA coronary laser atherectomy catheter, Spectranetics Laser Sheath (SLS) and Glidelight Laser Sheath devices.
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 |