SYNCHRONY III AND PARAGON III DUAL-CHAMBER PULSE GENERATORS
FDA premarket approval P880086/S032 · decided 1995-11-01
Approval details
- PMA number
- P880086
- Supplement
- S032
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SYNCHRONY III AND PARAGON III DUAL-CHAMBER PULSE GENERATORS
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- ABBOTT MEDICAL
- Date received
- 1995-08-02
- Decision date
- 1995-11-01
- Days to decision
- 91 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR ALTERNATIVE HYBRID SUBSTRATE
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