VITALITY HE MODELS T180 AND T182
FDA premarket approval P960040/S067 · decided 2005-07-27
Approval details
- PMA number
- P960040
- Supplement
- S067
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VITALITY HE MODELS T180 AND T182
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2005-07-12
- Decision date
- 2005-07-27
- Days to decision
- 15 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 THE COMPONENT; AND 2) PROGRAMMER SOFTWARE APPLICATION MODEL 2845 V2.8.
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