EXCIMER LASER CORONARY ATHERECTOMY (ELCA) CATHETER
FDA premarket approval P910001/S059 · decided 2013-04-04
Approval details
- PMA number
- P910001
- Supplement
- S059
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- EXCIMER LASER CORONARY ATHERECTOMY (ELCA) CATHETER
- Generic name
- DEVICE, ANGIOPLASTY, LASER, CORONARY
- Applicant
- Spectranetics Corp.
- Date received
- 2012-07-02
- Decision date
- 2013-04-04
- Days to decision
- 276 days
- Decision code
- APPR
- Product code
- LPC
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Colorado Springs, CO
- Statement
- APPROVAL FOR A CHANGE TO AN ADHESIVE PRIMER USED IN THE MANUFACTURE OF THE ELCA ECCENTRIC (ELL) DEVICES. PREVIOUSLY, YOU HAVE USED LOCTITE 793 WHICH HAS BEEN DISCONTINUED BY THE VENDOR. THE PRIMER HAS BEEN CHANGED TO LOCTITE 7701, A MEDICAL GRADE ADHESIVE PRIMER USED FOR THE SAME PURPOSE.
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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 |