PMA P010012S055
- Device
- CONTAK RENEWAL 3 MODELS H170, H173 & H175 AND CONTAK RENEWAL 3 HE MODELS H177 & H179
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S055
- Product code
- LWP
- Decision date
- 2005-07-29
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- APPROVAL TO REPLACE THE EXISTING POLYIMIDE TUBING THAT PROVIDES INSULATION IN THE PULSE GENERATOR HEADER ASSEMBLY WITH POLYETHERETHERKE-TONE (PEEK) TUBING.
Current openFDA PMA Record#
- Device
- CONTAK RENEWAL 3 MODELS H170, H173 & H175 AND CONTAK RENEWAL 3 HE MODELS H177 & H179
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S055
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2005-07-29
- Decision code
- APPR
- Date received
- 2005-07-06
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL TO REPLACE THE EXISTING POLYIMIDE TUBING THAT PROVIDES INSULATION IN THE PULSE GENERATOR HEADER ASSEMBLY WITH POLYETHERETHERKE-TONE (PEEK) TUBING.