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PG PROPONENT SR SL US, PG PROPONENT DR SL US, PG PROPONENT DR EL US, PG ACCOLADE SR SL US,PG ACCOLADE DR SL US, PG ACCOL

FDA premarket approval N970003/S288 · decided 2023-10-06

Approval details

PMA number
N970003
Supplement
S288
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
PG PROPONENT SR SL US, PG PROPONENT DR SL US, PG PROPONENT DR EL US, PG ACCOLADE SR SL US,PG ACCOLADE DR SL US, PG ACCOL
Generic name
Implantable pulse generator, pacemaker (non-CRT)
Applicant
Boston Scientific Corp
Date received
2023-09-20
Decision date
2023-10-06
Days to decision
16 days
Decision code
OK30
Product code
LWP
Advisory committee
Cardiovascular
Expedited review
No
Location
St Paul, MN
Statement
Update automatic optical inspection software at a supplier used to inspect implantable pulse generator components.

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