GEM MODEL 7227/MICROJEWEL MODELS 7221, 7223 ICDS
FDA premarket approval P900061/S039 · decided 2000-12-11
Approval details
- PMA number
- P900061
- Supplement
- S039
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- GEM MODEL 7227/MICROJEWEL MODELS 7221, 7223 ICDS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 1999-07-26
- Decision date
- 2000-12-11
- Days to decision
- 504 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR LABELING CHANGES OF THE MEDTRONIC MODELS 7221, 7223, 7227, 7229, 7271 AND 7273.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.