CONTAK RENEWAL MODELS H125 AND H120 WITH THE MODEL 2865 VERSION 1.8 APPLICATION SOFTWARE
FDA premarket approval P030005 · decided 2004-01-26
Approval details
- PMA number
- P030005
- Trade name
- CONTAK RENEWAL MODELS H125 AND H120 WITH THE MODEL 2865 VERSION 1.8 APPLICATION SOFTWARE
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Applicant
- Guidant Corp.
- Date received
- 2003-03-24
- Decision date
- 2004-01-26
- Days to decision
- 308 days
- Decision code
- APPR
- Product code
- NKE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR THE CONTAK RENEWAL TR. THE DEVICE IS INDICATED S FOLLOWS: THE CONTAK RENEWAL TR PULSE GENERATOR IS INDICATED FOR PATIENTS WHO HAVE MODERATE TO SEVERE HEART FAILURE (NYHA CLASS III/IV) INCLUDING LEFT VENTRICULAR DYSFUNCTION (EF <= 35%) AND QRS DURATION >= 120 MS AND REMAIN SYMPTOMATIC DESPITE STABLE, OPTIMAL HEART FAILURE DRUG THERAPY (AS DEFINED IN THE CLINICAL TRIALS SECTION). THE DEVICE PROVIDES ATRIAL-VENTRICULAR TRACKING MODES TO HELP PRESERVE AV SYNCHRONY, AND ADAPTIVE-RATE PAC
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510(k) clearances by this applicant
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|---|---|---|
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| 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 |