CONTAK RENEWAL, CONTAK RENEWAL 3, CONTAK RENEWAL 3 HE, CONTAK RENEWAL E RF, CONTAK RENEWAL 3 RF HE W/CONSULT PROG SFTWR
FDA premarket approval P010012/S056 · decided 2005-08-16
Approval details
- PMA number
- P010012
- Supplement
- S056
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CONTAK RENEWAL, CONTAK RENEWAL 3, CONTAK RENEWAL 3 HE, CONTAK RENEWAL E RF, CONTAK RENEWAL 3 RF HE W/CONSULT PROG SFTWR
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific Corp
- Date received
- 2005-07-12
- Decision date
- 2005-08-16
- Days to decision
- 35 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- 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.
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