VIGOR DR/SR PACEMAKER SYSTEM
FDA premarket approval P940031/S057 · decided 2006-07-26
Approval details
- PMA number
- P940031
- Supplement
- S057
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- VIGOR DR/SR PACEMAKER SYSTEM
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2006-06-26
- Decision date
- 2006-07-26
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- CHANGES TO THE SOFTWARE LOAD PROCESS FOR THE MODEL 3120 ZOOM LATITUDE PROGRAMMER USED WITH THE DEVICES.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.