PMA P030005S055
- Device
- INSIGNIA AND CONTAK RENEWAL TR PULSE GENERATORS
- Applicant
- Guidant Corp.
- PMA number
- P030005
- Supplement
- S055
- Product code
- NKE
- Decision date
- 2009-01-23
- Classification
- Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (crt-p)
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Approval order 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.
Current openFDA PMA Record#
- Device
- INSIGNIA AND CONTAK RENEWAL TR PULSE GENERATORS
- Applicant
- Guidant Corp.
- PMA number
- P030005
- Supplement
- S055
- Product code
- NKE
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Decision date
- 2009-01-23
- Decision code
- APPR
- Date received
- 2008-11-26
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order 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.