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.
Device | Aveir |
Generic Name | Leadless Pacemaker |
Applicant | Abbott 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 Received | 2022-09-21 |
Decision Date | 2022-10-06 |
PMA | P150035 |
Supplement | S002 |
Product Code | PNJ |
Advisory Committee | Cardiovascular |
Supplement Type | 30-day Notice |
Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
Expedited Review | No |
Combination Product | Yes |
Applicant Address | Abbott 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 |
Supplement Number | Date | Supplement Type |
---|---|---|
P150035 | Original Filing | |
S002 | 2022-09-21 | 30-day Notice |
S001 | 2022-04-18 | 30-day Notice |
Device ID | PMA | Supp |
---|---|---|
05415067036384 | P150035 | 000 |
05415067034472 | P150035 | 000 |
05415067031914 | P150035 | 000 |
05415067038487 | P150035 | 003 |
05415067040725 | P150035 | 003 |
05415067040701 | P150035 | 003 |