Aveir

FDA Premarket Approval P150035 S002

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

DeviceAveir
Generic NameLeadless Pacemaker
ApplicantAbbott Medical15900 Valley View Courtsylmar, CA 91342 PMA NumberP150035 Supplement NumberS002 Date Received09/21/2022 Decision Date10/06/2022 Product Code PNJ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-09-21
Decision Date2022-10-06
PMAP150035
SupplementS002
Product CodePNJ 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductYes
Applicant AddressAbbott Medical
15900 Valley View Court
sylmar, CA 91342 PMA NumberP150035 Supplement NumberS002 Date Received09/21/2022 Decision Date10/06/2022 Product Code PNJ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductYes Approval Order Statement  
to Add An Alternate Supplier For The Sub-processing Of The Wafer Level Chip Scale Package

Supplemental Filings

Supplement NumberDateSupplement Type
P150035Original Filing
S002 2022-09-21 30-day Notice
S001 2022-04-18 30-day Notice

NIH GUDID Devices

Device IDPMASupp
05415067036384 P150035 000
05415067034472 P150035 000
05415067031914 P150035 000
05415067038487 P150035 003
05415067040725 P150035 003
05415067040701 P150035 003

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