PMA P010012S056
- Device
- CONTAK RENEWAL, CONTAK RENEWAL 3, CONTAK RENEWAL 3 HE, CONTAK RENEWAL E RF, CONTAK RENEWAL 3 RF HE W/CONSULT PROG SFTWR
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S056
- Product code
- LWP
- Decision date
- 2005-08-16
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- APPROVAL FOR 1) AN ALTERNATE MAGNETIC REED SWITCH MANUFACTURED BY HERMETIC AND AN ASSOCIATED CHANGE TO THE EQUIPMENT USED IN THE REWORK OF THIS COMPONENT (ONLY IN CONTAK RENEWAL 3 RF MODELS H210, H215, H250 & H255 AND CONTAK RENEWAL 3 RF HE MODELS H217, H219, H257, & H259); AND 2) CONSULT PROGRAMMER SOFTWARE APPLICATION MODEL 2845 VERSION 4.12.
Current openFDA PMA Record#
- Device
- CONTAK RENEWAL, CONTAK RENEWAL 3, CONTAK RENEWAL 3 HE, CONTAK RENEWAL E RF, CONTAK RENEWAL 3 RF HE W/CONSULT PROG SFTWR
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S056
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2005-08-16
- Decision code
- APPR
- Date received
- 2005-07-12
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR 1) AN ALTERNATE MAGNETIC REED SWITCH MANUFACTURED BY HERMETIC AND AN ASSOCIATED CHANGE TO THE EQUIPMENT USED IN THE REWORK OF THIS COMPONENT (ONLY IN CONTAK RENEWAL 3 RF MODELS H210, H215, H250 & H255 AND CONTAK RENEWAL 3 RF HE MODELS H217, H219, H257, & H259); AND 2) CONSULT PROGRAMMER SOFTWARE APPLICATION MODEL 2845 VERSION 4.12.