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™ VR Leadless System: Aveir™ Leadless Pacemaker (Right Ventricular), Aveir™ Delivery System Catheter, Aveir™ Link M |
| Generic Name | Pulse-generator, Single Chamber, Sensor Driven, Implantable |
| Applicant | Abbott Medical15900 Valley View Courtsylmar, CA 91342 PMA NumberP150035 Supplement NumberS001 Date Received04/18/2022 Decision Date05/04/2022 Product Code LWO Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-04-18 |
| Decision Date | 2022-05-04 |
| PMA | P150035 |
| Supplement | S001 |
| Product Code | LWO |
| 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 NumberS001 Date Received04/18/2022 Decision Date05/04/2022 Product Code LWO Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductYes Approval Order Statement updating The Docking Button Cleaning Line From Manual To An Automated Cleaning System |
| 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 |