CYBERLITH IV UNIPOLAR PULSE GENERATOR
FDA premarket approval P800019/S003 · decided 1981-12-24
Approval details
- PMA number
- P800019
- Supplement
- S003
- Trade name
- CYBERLITH IV UNIPOLAR PULSE GENERATOR
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 1981-09-14
- Decision date
- 1981-12-24
- Days to decision
- 101 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.