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Essentio SR, Essentio DR, Essentio EL DR, Proponent SR, Proponent DR, Proponent EL DR, Accolade SR, Accolade DR, Accola

FDA premarket approval N970003/S246 · decided 2019-12-04

Approval details

PMA number
N970003
Supplement
S246
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
Essentio SR, Essentio DR, Essentio EL DR, Proponent SR, Proponent DR, Proponent EL DR, Accolade SR, Accolade DR, Accola
Generic name
Implantable pulse generator, pacemaker (non-CRT)
Applicant
Boston Scientific Corp
Date received
2019-12-03
Decision date
2019-12-04
Days to decision
1 days
Decision code
OK30
Product code
LWP
Advisory committee
Cardiovascular
Expedited review
No
Location
St Paul, MN
Statement
Add a post-reflow manufacturing inspection for printed circuit boards.

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