Medtronic Cardiac Rhythm Disease Management: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Medtronic Cardiac Rhythm Disease Management”, plus 8 PMA decisions, across 4 product codes in 1 review panel. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Medtronic, based on public ownership records.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NVN | Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes | 3 | 0 |
| LWP | Implantable Pulse Generator, Pacemaker (Non-Crt) | 2 | 0 |
| LWS | Implantable Cardioverter Defibrillator (Non-Crt) | 2 | 0 |
| NIK | Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) | 1 | 0 |
Review panels
- Cardiovascular (8)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P030036 | PMA | MEDTRONIC SELECTSECURE LEAD MODEL 3830 | 2005-08-03 |
| P010031 | PMA | CONCERTO/INSYNC SENTRY/INSYNC MAXIMO IMPLANTABLE CARDIOVASCULAR DEFIBRILLATORS WITH CARDIAC RESYNCHICNIZATION | 2002-06-26 |
| P980016 | PMA | VIRTUSO/ENTRUST/MAXIMO/INTRINSIC/MARQUIS/IMPLANTABLE CARDIVERTER DEFIBRILLATORS | 1998-10-09 |
| P900061 | PMA | MEDTRONIC PCD TACHYARRHYTHMIA CONTROL SYSTEM | 1993-02-11 |
| P850089 | PMA | CAPSURE SP, CAPSURE, CAPSURE 2 LEADS, EXCELLENCE S, IMPULSE, IMPLUSE II EXCELLENCE SS, LEADS | 1986-07-29 |
Recalls
openFDA lists no recalls under a recalling firm named Medtronic Cardiac Rhythm Disease Management.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Medtronic Cardiac Rhythm Disease Management (a text match, not an official crosswalk):
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Medtronic Vascular (480 510(k)s)
- Medtronic Sofamor Danek (253 510(k)s)
- Medtronic, Inc. (247 510(k)s)
- Medtronic Sofamor Danek USA, Inc. (182 510(k)s)
- Medtronic Minimed (57 510(k)s)
- Medtronic Xomed, Inc. (47 510(k)s)
- Medtronic Navigation, Inc. (44 510(k)s)
- Medtronic Perfusion Systems (29 510(k)s)
- Medtronic Neurosurgery (27 510(k)s)
- Medtronic Blood Systems, Inc. (15 510(k)s)
- Medtronic PS Medical (14 510(k)s)
- Medtronic Ave, Inc. (13 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Medtronic Cardiac Rhythm Disease Management?
FDA lists 0 510(k) clearances under the applicant name “Medtronic Cardiac Rhythm Disease Management”, plus 8 PMA decisions, across 4 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
Which FDA product codes appear under Medtronic Cardiac Rhythm Disease Management?
The most frequent FDA product codes under this applicant name are NVN (Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes, 3); LWP (Implantable Pulse Generator, Pacemaker (Non-Crt), 2); LWS (Implantable Cardioverter Defibrillator (Non-Crt), 2).
Next steps
- See all 0 Medtronic Cardiac Rhythm Disease Management clearances with predicates and recalls
- Run predicate analysis for product code NVN, Medtronic Cardiac Rhythm Disease Management's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.