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ESSENTIO SR, ESSENTIO DR, PROPONENT SR, PROPONENT DR, ACCOLADE SR, ACCOLADE DR, ALTRUA 2 DR, ALTRUA 2 SR

FDA premarket approval N970003/S268 · decided 2021-09-24

Approval details

PMA number
N970003
Supplement
S268
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
ESSENTIO SR, ESSENTIO DR, PROPONENT SR, PROPONENT DR, ACCOLADE SR, ACCOLADE DR, ALTRUA 2 DR, ALTRUA 2 SR
Generic name
Implantable pulse generator, pacemaker (non-CRT)
Applicant
Boston Scientific Corp
Date received
2021-09-23
Decision date
2021-09-24
Days to decision
1 days
Decision code
OK30
Product code
LWP
Advisory committee
Cardiovascular
Expedited review
No
Location
St Paul, MN
Statement
Change the adhesive and liner used on the tray label stock for pulse generators and Leads.

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