DUAL-CHAMBER ADAPTIVE-RATE PACEMAKER
FDA premarket approval P940031/S067 · decided 2010-05-20
Approval details
- PMA number
- P940031
- Supplement
- S067
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- DUAL-CHAMBER ADAPTIVE-RATE PACEMAKER
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2010-04-20
- Decision date
- 2010-05-20
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- ELIMINATION OF THE OUTER SLEEVE WASH STEP.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.