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 | QUIK-PAK Electrodes |
| Generic Name | Automated External Defibrillators (non-wearable) |
| Applicant | Physio-Control. Inc.11811 Willows Rd. Neredmond, WA 98052 PMA NumberP160012 Supplement NumberS006 Date Received05/16/2022 Decision Date07/20/2022 Product Code MKJ Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No |
| Date Received | 2022-05-16 |
| Decision Date | 2022-07-20 |
| PMA | P160012 |
| Supplement | S006 |
| Product Code | MKJ |
| Advisory Committee | Cardiovascular |
| Supplement Type | Real-time Process |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Physio-Control. Inc. 11811 Willows Rd. Ne redmond, WA 98052 PMA NumberP160012 Supplement NumberS006 Date Received05/16/2022 Decision Date07/20/2022 Product Code MKJ Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No Combination ProductNo Approval Order Statement Approval For A Temporary Shelf-life Extension Up To 9 Months Beyond The Expiration Date For Units Already Distributed In The Field That Meet The Required Storage Conditions. |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P160012 | Original Filing | |
| S006 | 2022-05-16 | Real-time Process |
| S005 | ||
| S004 | 2020-04-16 | 30-day Notice |
| S003 | ||
| S002 | ||
| S001 |
| Device ID | PMA | Supp |
|---|---|---|
| 00883873824610 | P160012 | 002 |
| 00883873824603 | P160012 | 002 |
| 00883873824597 | P160012 | 002 |