AngioSculpt® Evo RX PTCA Scoring Balloon Catheter with Hydrophilic Coating (AngioSculpt Evo catheter)
FDA premarket approval P050018/S030 · decided 2021-12-23
Approval details
- PMA number
- P050018
- Supplement
- S030
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- AngioSculpt® Evo RX PTCA Scoring Balloon Catheter with Hydrophilic Coating (AngioSculpt Evo catheter)
- Generic name
- Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
- Applicant
- Spectranetics Corp.
- Date received
- 2021-03-08
- Decision date
- 2021-12-23
- Days to decision
- 290 days
- Decision code
- APPR
- Product code
- NWX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Fremont, CA
- Statement
- Approval for the addition of a pre-coating plasma treatment step.
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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 |