INTERTACH(R) II IMPLANT. PACEMAKER PULSE GENERATOR
FDA premarket approval P860007/S005 · decided 1991-07-02
Approval details
- PMA number
- P860007
- Supplement
- S005
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- INTERTACH(R) II IMPLANT. PACEMAKER PULSE GENERATOR
- Generic name
- PULSE-GENERATOR, SINGLE CHAMBER, SINGLE
- Applicant
- Boston Scientific
- Date received
- 1990-12-20
- Decision date
- 1991-07-02
- Days to decision
- 194 days
- Decision code
- APPR
- Product code
- LWW
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
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