INTERTACH TM IMPLANTABLE PACEMAKER PULSE
FDA premarket approval P860007/S002 · decided 1989-10-16
Approval details
- PMA number
- P860007
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- INTERTACH TM IMPLANTABLE PACEMAKER PULSE
- Generic name
- PULSE-GENERATOR, SINGLE CHAMBER, SINGLE
- Applicant
- Boston Scientific
- Date received
- 1989-05-09
- Decision date
- 1989-10-16
- Days to decision
- 160 days
- Decision code
- APPR
- Product code
- LWW
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
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