CRT-P Resynchronization Devices: INVIVE, INTUA, VISIONIST, and VALITUDE
FDA premarket approval P030005/S188 · decided 2019-10-18
Approval details
- PMA number
- P030005
- Supplement
- S188
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CRT-P Resynchronization Devices: INVIVE, INTUA, VISIONIST, and VALITUDE
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Applicant
- Guidant Corp.
- Date received
- 2019-07-22
- Decision date
- 2019-10-18
- Days to decision
- 88 days
- Decision code
- APPR
- Product code
- NKE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for modifying the Model 3300 LATITUDE Programming System software components to update the Brady device application code base, add support for 4G cellular communications, and add an integrated Heart Connect application.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| FLEX 10 MIS ABLATION PROBE, MODEL FLX10MI-05 (K061865) | Guidant Corp. | 2006-07-27 |
| HI-TORQUE WHISPER VIEW GUIDE WIRE (K061453) | Guidant Corp. | 2006-06-22 |
| RX ACCUNET 2 EMBOLIC PROTECTION SYSTEM (K042908) | Guidant Corp. | 2004-11-12 |
| ACCUNET EMBOLIC PROTECTION SYSTEM, RX ACCUNET EMBOLIC PROTECTION SYSTEM (K042218) | Guidant Corp. | 2004-08-31 |
| OMNILINK .018 BILIARY STENT SYSTEM (K033834) | Guidant Corp. | 2004-01-02 |
| ABSOLUTE .035 SELF-EXPANDING BILIARY STENT SYSTEM (K033393) | Guidant Corp. | 2003-11-10 |
| HI-TORQUE BALANCE INIVERSAL GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING (K031678) | Guidant Corp. | 2003-08-26 |
| RAPIDO CUT-AWAY CUTTER (K031459) | Guidant Corp. | 2003-07-23 |