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PG ESSENTIO SR/DR SL, PG PROPONENT SR/DR SL, DR EL, PG ACCOLADE SR/DR SL, DR EL, PG ALTRUA 2 SR/DR SL, DR EL

FDA premarket approval N970003/S248 · decided 2020-01-28

Approval details

PMA number
N970003
Supplement
S248
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
PG ESSENTIO SR/DR SL, PG PROPONENT SR/DR SL, DR EL, PG ACCOLADE SR/DR SL, DR EL, PG ALTRUA 2 SR/DR SL, DR EL
Generic name
Implantable pulse generator, pacemaker (non-CRT)
Applicant
Boston Scientific Corp
Date received
2020-01-27
Decision date
2020-01-28
Days to decision
1 days
Decision code
OK30
Product code
LWP
Advisory committee
Cardiovascular
Expedited review
No
Location
St Paul, MN
Statement
Reduce the burn-in process temperature setting used during manufacturing of the Integrated Circuit modules of the NG3/NG4 and Accolade Pulse Generator product families.

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