DELTA PACEMAKER SYSTEM
FDA premarket approval P840068/S044 · decided 2006-07-26
Approval details
- PMA number
- P840068
- Supplement
- S044
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- DELTA 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.