MODEL 3140 ZOOM WIRELESS TRANSMITTER AND MODEL 3120 ZOOM LATITUDE PROGRAMMER/RECORDER/MONITOR (PRM)
FDA premarket approval P910077/S139 · decided 2014-04-11
Approval details
- PMA number
- P910077
- Supplement
- S139
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MODEL 3140 ZOOM WIRELESS TRANSMITTER AND MODEL 3120 ZOOM LATITUDE PROGRAMMER/RECORDER/MONITOR (PRM)
- Generic name
- Pacemaker/icd/crt non-implanted components
- Applicant
- Boston Scientific
- Date received
- 2013-09-30
- Decision date
- 2014-04-11
- Days to decision
- 193 days
- Decision code
- APPR
- Product code
- OSR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR THE FOLLOWING CHANGES:1) NEW PULSE GENERATOR MODELS LISTED ABOVE AND MODIFICATIONS TO THE MODEL 2868 PROGRAMMER APPLICATION SOFTWARE USED TO COMMUNICATE WITH THE NEW DEVICES AND EXISTING DEVICES; AND 2) MODEL 3140 ZOOM WIRELESS TRANSMITTER AND ASSOCIATED MODIFICATIONS TO THE MODEL 3120 PRM SOFTWARE.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.