INSIGNIA AND CONTAK RENEWAL TR PULSE GENERATORS
FDA premarket approval P030005/S055 · decided 2009-01-23
Approval details
- PMA number
- P030005
- Supplement
- S055
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- INSIGNIA AND CONTAK RENEWAL TR PULSE GENERATORS
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Applicant
- Guidant Corp.
- Date received
- 2008-11-26
- Decision date
- 2009-01-23
- Days to decision
- 58 days
- Decision code
- APPR
- Product code
- NKE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR: 1) REPLACEMENT OF THE POLYMIDE TUBING WITH POLYETHERETHERKTONE (PEEK) TUBING ON THE PULSE GENERATOR PG HEADER ASSEMBLIES; 2) THE USE OF A COMBINATION OF NATURAL AND COLORIZED PEEK TO ASSIST MANUFACTURING OPERATORS; AND 3) THE ADDITION OF AN EXTRA PLASMA CLEANING STEP TO ENSURE THAT THE BOND FORMED BETWEEN THE MEDICAL ADHESIVE APPLIED TO THE BASE OF THE WIRE AND THE PEEK INSULATION IS STRONG.
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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 |